September 11-12, 2023 Meeting of the Nonprescription Drugs Advisory Committee (NDAC) - Day 2 U.S. Food and Drug Administration 2023-09-12 | The committee will discuss new data regarding the ‘Generally Recognized as Safe and Effective’ (GRASE) status of oral phenylephrine as a nasal decongestant that has become available over the years since FDA last examined the issue.
Clinical Investigator Training Course (CITC 2022) U.S. Food and Drug Administration 2022-12-08 | This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
123rd Meeting of the Blood Products Advisory Committee (BPAC) U.S. Food and Drug Administration 2022-12-08 | The committee will meet to hear an overview of CBER research programs.
FDA Webinar on the Food Traceability Final Rule U.S. Food and Drug Administration 2022-12-07 | The U.S. Food & Drug Administration (FDA) will hold an informational webinar on Wednesday, December 7, 2022, from 1:00 pm-5:00pm (ET) on the recently released Food Traceability final rule issued under the FDA Food Safety Modernization Act (FSMA). The final rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths. During the webinar, the FDA will provide an overview of the final rule, including the foods and entities covered by the rule, explain the exemptions from the rule, and discuss the recordkeeping and disclosure requirements of the rule. If you have additional questions on the Food Traceability Final Rule, please submit them to FDA’s Food and Cosmetics Information Center (FCIC) via the following web link: cfsan.secure.force.com/InquirypageSubmitting your question online enables us to track and trend all electronic inquiries and continually improve our process. For additional information on the Food Traceability Final Rule, see the FSMA Final Rule for Food Traceability website. Link to final rule web page: fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
FDA Clinical Investigator Training Course (CITC) 2022 U.S. Food and Drug Administration 2022-12-07 | This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions U.S. Food and Drug Administration 2022-12-06 | Updated enhancements to the PFC program include modified criteria for FDA to assess and act on priority ANDAs (originals, supplements, and amendments) within 8 months of the date of ANDA submission.
Why should I get a flu vaccine and what strains are included? – Just a Minute! with Dr. Peter Marks U.S. Food and Drug Administration 2022-12-06 | Still pondering that flu vaccine? Dr. Peter Marks is here with what you need to know about the flu vaccine and the included strains. #JustAMinute
Equity of Voices series: Dorine’s story U.S. Food and Drug Administration 2022-12-01 | The Equity of Voices video series features the stories of people living with HIV and the positive impact of antiretroviral therapy (ART) on their lives. This is Dorine’s story.
Equity of Voices series: Vincent’s story U.S. Food and Drug Administration 2022-12-01 | The Equity of Voices video series features the stories of people living with HIV and the positive impact of antiretroviral therapy (ART) on their lives. This is
Equity of Voices series: William’s story U.S. Food and Drug Administration 2022-12-01 | The Equity of Voices video series features the stories of people living with HIV and the positive impact of antiretroviral therapy (ART) on their lives. This is William’s story.
Equity of Voices series: Leah’s story U.S. Food and Drug Administration 2022-12-01 | The Equity of Voices video series features the stories of people living with HIV and the positive impact of antiretroviral therapy (ART) on their lives. This is Leah’s story.
Equity of Voices series: Lesters Story U.S. Food and Drug Administration 2022-12-01 | The Equity of Voices video series features the stories of people living with HIV and the positive impact of antiretroviral therapy (ART) on their lives. This is Lester’s story.
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions U.S. Food and Drug Administration 2022-11-30 | This event will discuss the two Drug Master File (DMF) enhancements specified under the Generic Drug User Fee Amendments (GDUFA) III Commitment Letter so as to help the industry better understand the changes in GDUFA III and its potential benefits.
Application of Risk Management Principles for Medical Devices U.S. Food and Drug Administration 2022-11-30 | This CDRH Learn module explains U.S. FDA's thoughts on the application of risk management principles for medical devices. It provides important information on risk analysis tools and review of benefit-risk information, including concepts from ISO 13485:2019. To view more educational resources please visit fda.gov/training-and-continuing-education/cdrh-learn.
Risk Basics for Medical Devices U.S. Food and Drug Administration 2022-11-30 | This CDRH Learn module explains U.S. FDA's thoughts on the basics of medical device risk. It provides important definitions, describes basic concepts and lays foundational knowledge on the topic of risk and its use throughout the total product life cycle. To view more educational resources please visit fda.gov/training-and-continuing-education/cdrh-learn.
¿Qué hace la Administración de Alimentos y Medicamentos? U.S. Food and Drug Administration 2022-11-28 | La Administración de Alimentos y Medicamentos regula los alimentos, medicamentos, cosméticos, productos biológicos, dispositivos médicos y productos de tabaco. Los investigadores en la Administración de Alimentos y Medicamentos incluso promueven la salud pública ya que ayudan a acelerar la innovación en los productos. Más de 18,000 empleados de tiempo completo trabajan en los 50 estados y en el mundo.. Por más de 100 años, la Administración de Alimentos y Medicamentos ha trabajado para llevar adelante su misión de promover y proteger la salud pública, y esto significa la salud de todos. Suscríbase al canal de YouTube de la Administración de Alimentos y Medicamentos y vea más videos para obtener más información.
What is a State Liaison: Trusted Partner U.S. Food and Drug Administration 2022-11-28 | This video showcases how FDA State Liaisons work cooperatively building trust with our state counterparts through longstanding relationships with the District/Division staff, while attending meetings, training, and problem solving together.
Role of a State Liaison-Communication Matters U.S. Food and Drug Administration 2022-11-28 | This video provides insight into the role of an FDA State Liaison and how the position helps bridge the gap between FDA and our state counterparts by striving to maintain strong working relationships through effective communication.
Being a State Liaison-Collaboration U.S. Food and Drug Administration 2022-11-28 | This video highlights how FDA State Liaisons work in a collaborative environment building relationships and trust with our state counterparts through mutual acceptance and reliance to support FDA’s mission of protecting public health.
What does the future hold for FDA’s efforts to address COVID? – Just a Minute! with Dr. Peter Marks U.S. Food and Drug Administration 2022-11-22 | There's still work to do in addressing the COVID-19 pandemic. Dr. Peter Marks explains what the FDA will be doing about it in the future. #JustAMinute
FDA Webinar on the Infant Formula Transition Plan (Part 4) U.S. Food and Drug Administration 2022-11-17 | The U.S. Food & Drug Administration (FDA) hosted the final part of a 4-part webinar series on Thursday, November 17, 2022 at 2 pm ET to provide more in-depth information on the Quality Factor Requirement of Normal Physical Growth and address questions.The Infant Formula Transition Plan for Exercise of Enforcement Discretion guidance outlines a pathway for manufacturers of infant formula under enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements while they work toward meeting those requirements. Under the new guidance, the period of enforcement discretion for those products identified in the letters of enforcement discretion will be extended until Jan. 6, 2023, with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the United States. The guidance balances the need to ensure that infant formula products meet regulatory requirements with the need for a more resilient infant formula supply. Links:Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion - fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretionPreamble to Infant Formula Interim Final Rule (February 2014) - federalregister.gov/documents/2014/02/10/2014-02148/current-good-manufacturing-practices-quality-control-procedures-quality-factors-notification Preamble to Infant Formula Final Rule (June 2014) - federalregister.gov/documents/2014/06/10/2014-13384/current-good-manufacturing-practices-quality-control-procedures-quality-factors-notificationGuidance for Industry: E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r121 CFR 50 - Protection of Human Subjects - ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50 21 CFR 56 - Institutional Review Boards - ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56 MedDRA: Medical Dictionary of Regulatory Activities - meddra.orgWHODrug Global (Drug Reference Dictionary) - who-umc.org/whodrug/whodrug-global
Are the new bivalent COVID-19 vaccines safe? – Just a Minute! with Dr. Peter Marks U.S. Food and Drug Administration 2022-11-17 | Dr. Peter Marks says "getting a bivalent vaccine booster dose is critical to help protect yourself against the most severe outcomes of COVID-19 including hospitalization and death." Watch this episode of #JustAMinute.
Food Traceability Final Rule Webinar U.S. Food and Drug Administration 2022-11-17 | The U.S. Food & Drug Administration (FDA) will hold an informational webinar on Wednesday, December 7th, 2022, from 1:00 pm - 5:00 pm (ET) on the recently released Food Traceability final rule issued under the FDA Food Safety Modernization Act (FSMA).
Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements U.S. Food and Drug Administration 2022-11-17 | In this webinar, FDA discusses a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, that is intended to minimize the impact of FDA running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.Timestamps02:02 – Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode RequirementsSpeaker:Leyla Rahjou-Esfandiary, Pharm. D.Lead Consumer Safety OfficerDrug Registration and Listing Branch | Division of Labeling, Registration, and Unapproved DrugsOffice of Unapproved Drugs and Labeling Compliance | Office of Compliance | CDER | FDALearn more at: fda.gov/drugs/drug-approvals-and-databases/proposed-rule-revising-national-drug-code-format -----------------------FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.Upcoming Training - fda.gov/cdersbiaSBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2022 Playlist - youtube.com/playlist?list=PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - fda.gov/cdersbialearn Twitter - twitter.com/FDA_Drug_Info Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367
November 16, 2022 Meeting of the Cardiovascular and Renal Drugs Advisory Committee U.S. Food and Drug Administration 2022-11-16 | The committee will discuss new drug application (NDA) 213931, for tenapanor hydrochloride tablets, submitted by Ardelyx, Inc. for the control of serum phosphorus levels in adults with chronic kidney disease on dialysis. The committee will be asked to comment on whether the size of the treatment effect on serum phosphorus is clinically meaningful and whether tenapanor’s benefits outweigh its risks.
How the Food Traceability Rule works: Seafood Supply Chain Example U.S. Food and Drug Administration 2022-11-15 | In this short presentation, the FDA uses a progression of supply chain graphics to explain how the Food Traceability Rule could apply to a seafood supply chain.
How the Food Traceability Rule works: Produce Supply Chain Example U.S. Food and Drug Administration 2022-11-15 | In this short presentation, the FDA uses a progression of supply chain graphics to explain how the Food Traceability Rule could apply to a fresh cucumber supply chain.
How the Food Traceability Rule works: Cheese Supply Chain Example U.S. Food and Drug Administration 2022-11-15 | In this short presentation, the FDA uses a progression of supply chain graphics to explain how the Food Traceability Rule could apply to a cheese supply chain.
FDA Drug Topics Understanding Generic Narrow Therapeutic Index Drugs November 1, 2022 U.S. Food and Drug Administration 2022-11-15 | ...
FDA Webinar on the Infant Formula Transition Plan (Part 3) U.S. Food and Drug Administration 2022-11-10 | The U.S. Food & Drug Administration (FDA) hosted Part 3 of a 4-part webinar series on Thursday, November 10, 2022 at 2 pm ET to provide more in-depth information on the Quality Factor Requirement of Sufficient Biological Quality of Protein.The Infant Formula Transition Plan for Exercise of Enforcement Discretion guidance outlines a pathway for manufacturers of infant formula under enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements while they work toward meeting those requirements. Under the new guidance, the period of enforcement discretion for those products identified in the letters of enforcement discretion will be extended until Jan. 6, 2023, with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the United States. The guidance balances the need to ensure that infant formula products meet regulatory requirements with the need for a more resilient infant formula supply. Register to Webinar Series - surveymonkey.com/r/MVHQ337.Links:Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion - fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretion
November 9, 2022 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) U.S. Food and Drug Administration 2022-11-09 | The committee will discuss the request for Emergency Use Authorization 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. A focus of the discussion will include the treatment effect size in the context of the high placebo mortality rate, the limited size of the safety database, and identifying the proposed population.
Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation U.S. Food and Drug Administration 2022-11-09 | The FDA Office of Women's Health in collaboration with CDER’s Division of Pediatrics and Maternal Health hosted a follow-up webinar on October 27, 2022 titled: Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation. This presentation aimed to build on a previous discussion about the FDA’s current pregnancy and lactation labeling system, also known as the Pregnancy and Lactation Labeling Rule (PLLR). Although the PLLR improved the presentation of information in prescription medication labeling, it highlighted the gaps in human data for medications used during pregnancy and lactation. This presentation provided an overview of the studies enrolling pregnant and lactating individuals, the work FDA is doing to advance research in pregnant and lactating individuals, and information on how providers can become involved in advancing research in pregnant and lactating individuals.Learn more: fda.gov/consumers/public-meetings-workshops-and-webinars/engaging-providers-address-knowledge-gaps-medication-use-pregnancy-and-lactation
November 8, 2022 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) U.S. Food and Drug Administration 2022-11-08 | The committee will discuss the new drug application 214070, for a fixed dose combination of budesonide and albuterol sulfate metered dose inhaler, submitted by AstraZeneca and Bond Avillion 2 Development LP. The proposed indication is as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.
La Administración de Alimentos y Medicamentos autoriza la comercialización de una nueva prueba... U.S. Food and Drug Administration 2022-11-07 | La Administración de Alimentos y Medicamentos de Estados Unidos autorizó hoy la comercialización de la primera prueba de diagnóstico in vitro para la detección temprana de placas amiloides asociadas con la enfermedad de Alzheimer. Obtenga más información: fda.gov/news-events/press.
Why should I get my child an updated COVID-19 vaccine? – Just a Minute! with Dr. Peter Marks U.S. Food and Drug Administration 2022-11-07 | Last week, we shared why YOU should get an updated COVID-19 vaccine. Now, Dr. Peter Marks is here to explain why your child should also! #JustAMinute
FDA Webinar on New Infant Formula Transition Plan (Part 2) U.S. Food and Drug Administration 2022-11-04 | The U.S. Food & Drug Administration (FDA) hosted Part 2 of a 4-part webinar series on Friday, November 4, 2022, at 2 pm ET to provide more in-depth information about new infant formula submission requirements and recommendations and address questions.The Infant Formula Transition Plan for Exercise of Enforcement Discretion guidance outlines a pathway for manufacturers of infant formula under enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements while they work toward meeting those requirements. Under the new guidance, the period of enforcement discretion for those products identified in the letters of enforcement discretion will be extended until Jan. 6, 2023, with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the United States. The guidance balances the need to ensure that infant formula products meet regulatory requirements with the need for a more resilient infant formula supply. Register to Webinar Series - surveymonkey.com/r/MVHQ337.Links:Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion - fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretion Infant Formula Guidance Documents & Regulatory Information - fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/infant-formula-guidance-documents-regulatory-information Preamble to Infant Formula Interim Final Rule (February 2014) -federalregister.gov/documents/2014/02/10/2014-02148/current-good-manufacturing-practices-quality-control-procedures-quality-factors-notification Preamble to Infant Formula Final Rule (June 2014) - federalregister.gov/documents/2014/06/10/2014-13384/current-good-manufacturing-practices-quality-control-procedures-quality-factors-notificationExempt Infant Formula Guidance - fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exempt-infant-formula-production
Language Assistance Services for Retailers Who Have Received a Tobacco CMP or NTSO Complaint U.S. Food and Drug Administration 2022-11-04 | This webinar provides information on the Center for Tobacco Products’ language access services (i.e., translation services) for tobacco retailers who have limited English proficiency and need assistance to understand how to pay their Civil Money Penalty (CMP) or settle their case after they have received a CMP or No-Tobacco-Sale Order Complaint.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting (PSCP) U.S. Food and Drug Administration 2022-11-03 | On November 3, 2022, as part of CDER’s continued effort to provide key updates on modernization of quality assessment, the committee will discuss the next stages of Knowledge-Aided Assessment and Structured Application (KASA). The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting on September 20, 2018, as an IT system that modernizes FDA’s assessment. Through the development, testing, and implementation of various KASA prototypes, the KASA system has been refined over the course of multiple years. FDA will seek input on the vision and plan to expand KASA over the next 5 years to include drug substances, all generic dosage forms, new drug and biologics applications, and post-approval changes. Moreover, FDA will seek input regarding the need for advancing digitalization in KASA, including data standardization and mobilization of data from cloud-based servers.Meeting Information and Materials: fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2022-pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting#event-information
Why should I get the updated COVID-19 vaccine now? – Just a Minute! with Dr. Peter Marks U.S. Food and Drug Administration 2022-11-03 | There's a pretty good reason why you should get the updated COVID-19 vaccine now. Here's Dr. Peter Marks with more... #JustAMinute
FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines - September 27, 2022 U.S. Food and Drug Administration 2022-11-02 | ...
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting (PSCP) U.S. Food and Drug Administration 2022-11-02 | On November 2, 2022, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry, drug shortages, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices.Meeting Information and Materials: fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2022-pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting#event-information
What is RSV and are there ways to prevent & treat this virus? – Just a Minute! with Dr. Peter Marks U.S. Food and Drug Administration 2022-10-31 | Do you know about RSV? What is it, and are there ways to prevent and treat this virus? Dr. Peter Marks has the answers on this episode of "Just a Minute!"
October 28, 2022 Meeting of the Oncologic Drugs Advisory Committee (ODAC) U.S. Food and Drug Administration 2022-10-28 | The Committee will discuss biologics license application 761176 for 131I-omburtumab solution for injection, submitted by Y-mAbs Therapeutics, Inc. for the proposed indication of treatment of neuroblastoma with central nervous system/leptomeningeal metastases.Meeting Information and Materials: fda.gov/advisory-committees/advisory-committee-calendar/updated-agenda-information-october-28-2022-meeting-oncologic-drugs-advisory-committee-meeting
Mambo ya Ngozi! Mpango wa PSA U.S. Food and Drug Administration 2022-10-27 | FDA imezindua Jarida kuhusu Ngozi! mpango wa kuwatahadharisha watumiaji kuhusu uwezekano wa madhara yanayosababishwa na bidhaa za ngozi zinazonunuliwa dukani (OTC) zenye hidrokwinoni au zebaki bila ushauri wa daktari. Bidhaa hizi hazijaidhinishwa na FDA kwa ajili ya kuuzwa dukani. Pata Jarida kuhusu Ngozi kwa kutembelea www.fda.gov/skinfacts
Mambo ya Ngozi! Mpango wa PSA U.S. Food and Drug Administration 2022-10-27 | FDA imezindua Jarida kuhusu Ngozi! mpango wa kuwatahadharisha watumiaji kuhusu uwezekano wa madhara yanayosababishwa na bidhaa za ngozi zinazonunuliwa dukani (OTC) zenye hidrokwinoni au zebaki bila ushauri wa daktari. Bidhaa hizi hazijaidhinishwa na FDA kwa ajili ya kuuzwa dukani. Pata Jarida kuhusu Ngozi kwa kutembelea www.fda.gov/skinfacts
An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs U.S. Food and Drug Administration 2022-10-27 | FDA provided additional clarity to the final guidance with respect to Agency expectations for submissions containing BA information for drug products. Timestamps00:27 – Opening Comments03:37 – Bioavailability Studies Submitted in NDAs and INDs – General Considerations24:33 – Bioavailability Determination: Special Topics50:08 – Relative Bioavailability Evaluation: Potential for Using Pharmacodynamic and Non-Traditional Pharmacokinetic Endpoints 1:10:57 – Recommended In Vitro Studies 1:40:40 – Q&A Discussion with All PresentersSpeakers:Ethan Stier, PhD.Associate Director, Lifecycle ManagementImmediate Office (IO) | Office of Clinical Pharmacology (OCP)Office of Translational Sciences (OTS) | CDERDakshina Chilukuri, PhD.Team LeaderDivision of Infectious Disease Pharmacology (DIDP) | OCP| CDERJayabharathi Vaidyanathan, PhD.Associate Director for Therapeutic ReviewDivision of Cardiometabolic and Endocrine Pharmacology (DCEP) | OCP| CDERKofi A. Kumi, Ph.D., R. Ph. Senior Reviewer, Clinical Pharmacology Division of Neuropsychiatric Pharmacology (DNP) | OCP | OTS | CDER Okponanabofa Eradiri, PhD Branch Chief Division of Biopharmaceutics (DP) | Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) | CDER | FDA Panelists: Ethan Stier, Dakshina Chilukuri, Jayabharathi Vaidyanathan, Kofi A. Kumi, and Okponanabofa Eradiri Learn more at: fda.gov/drugs/news-events-human-drugs/depth-look-final-fda-guidance-bioavailability-studies-submitted-ndas-or-inds-general-considerations -----------------------FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.Upcoming Training - fda.gov/cdersbiaSBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2022 Playlist - youtube.com/playlist?list=PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - fda.gov/cdersbialearn Twitter - twitter.com/FDA_Drug_Info Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367
October 26, 2022 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) U.S. Food and Drug Administration 2022-10-26 | The committee will discuss new drug application (NDA) 216951, for the hypoxia inducible factor prolyl hydroxylase inhibitor, daprodustat tablets, submitted by GlaxoSmithKline, LLC, for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis.
How FDA Investigates Foodborne Illness Outbreaks U.S. Food and Drug Administration 2022-10-26 | Learn how foodborne illness outbreaks are investigated. This video shows what FDA does to ensure the food supply is safe and how it identifies and removes food from the market that is causing people to get sick. It explains each step of the investigation and how CDC, FDA, and state public health laboratories work together to solve the mystery using science and modern technologies such as whole genome sequencing.The CDC estimates that about 48 million people get sick each year from foodborne pathogens in the United States. Some of the more well-known causes of recent outbreaks include Salmonella, Listeria, E. coli, and Cyclospora. To reduce outbreaks of foodborne illness, we must remain focused on prevention. To speed up outbreak investigations, we must leverage new technologies to create a more traceable digital food system.For more information about foodborne outbreaks, you can follow FDA on Twitter and sign up for food safety alerts at the FDA website.twitter.com/FDAfoodfda.gov/food/recalls-outbreaks-emergencies/outbreaks-foodborne-illness
Mga Katotohanan sa Balat! Ang Kailangan Mong Malaman Tungkol sa Mga Produktong Pangpaputi ng Balat U.S. Food and Drug Administration 2022-10-25 | Mga Katotohanan sa Balat! ay bagong inisyatiba ng FDA upang makatulong sa pagtukoy at pagiwas ng mga nakakapinsalang sangkap sa mga produktong pampaputi ng balat. Maaaring gamitin ang mga produktong pampaputi ng balat upang lumiwanag o itama ang hindi pantay na kulay ng balat para sa mga kondisyon tulad ng mga dark spots, acne, at wrinkles. Maaari silang ibenta bilang mga fading cream, bleaching agent, o chemical peels. Alamin kung ano ang nasa iyong mga produkto sa balat sa pamamagitan ng pagsuri sa listahan ng mga sangkap sa mga label ng produkto. Makipag-usap sa iyong health care provider bago gumamit ng skin lightening product. Kunin ang Skin Facts sa pamamagitan ng pagbisita sa www.fda.gov/skinfacts
スキン・ファクト！FDAの新たな取り組み U.S. Food and Drug Administration 2022-10-25 | 米国食品医薬品局（FDA）のマイノリティ・ヘルスおよび健康公平局は、ハイドロキノンや水銀を含む、有害な可能性のある市販（OTC）スキンケア製品について、消費者に警告する新しい公衆教育の取り組み、スキン・ファクト！（Skin Facts!）を開始しました。これらの製品はFDAに店頭販売を承認されておらず、健康に害を及ぼす可能性があります。www.fda.gov/SkinFactswww.fda.gov/HealthEquityで、スキン・ファクトにアクセス。
¡Sólo un minuto! con el Dr. Peter Marks #4 Administración intradérmica, vacuna para viruela del mono U.S. Food and Drug Administration 2022-10-24 | ¿Se pregunta por qué ahora permitimos la administración intradérmica de la vacuna contra la #ViruelaDelMono? El Dr. Peter Marks explica lo que esto significa en #SóloUnMinuto fda.gov/about-fda/fda-en-espanol/respuesta-de-la-fda-la-viruela-del-mono
