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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward
… /statement-fda-commissioner-scott-gottlieb-md-director-fdas-center-drug-evaluation-and-research-janet … For more than 30 … even in circumstances where the availability of a medicine through EA would appropriately balance these … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
… is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for … M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed …
FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
… medicines should continue taking their medicine until they have a replacement product. To determine … said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. The FDA will … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Speech by Commissioner Robert M. Califf to the House of Medicine - 06/16/2023
… hes-fda-officials/speech-commissioner-robert-m-califf-house-medicine-06162023 … (Remarks as prepared for delivery) Good … the study done near the beginning of the pandemic by the Center for Countering Digital Hate, which found that just 12 … House of Medicine Washington, DC June 16, 2023 … Animal & Veterinary … Biologics … Drugs … Food & Beverages … Medical …
FDA In Brief: FDA requires new warnings for gabapentinoids about risk of respiratory depression
… M.D., deputy director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research: “With the evolution … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Remarks to the Alliance for a Stronger FDA - 04/10/2019
… product offices have been busy as well. Last year our Center for Drug Evaluation and Research approved a record 59 … way to do that is getting unused medications out of the medicine chest. Under the SUPPORT Act, we can require … “directorates” Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, …
Dr. Hahn's remarks to the Alliance for Health Policy Brazda Breakfast Briefing - 01/08/2021
… of courage and resolve. The FDA has been in the center of the efforts to combat this public health emergency, … outbreaks of Shiga-toxin producing E. coli. Our Center for Veterinary Medicine (CVM) made history with the approval of the first …
FDA Advancing Beneficial Animal Biotechnology Product Development
… We also want to provide an update on the FDA’s Center for Veterinary Medicine’s Veterinary Innovation Program. This is a key part …
FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older
… Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Based on their … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age
… of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. “In addition, prior … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Remarks by Dr. Woodcock at the 50th Anniversary Celebration of the FDA's National Center for Toxicological Research - 08/12/2021
… arks-dr-woodcock-50th-anniversary-celebration-fdas-national-center-toxicological-research … (Remarks as prepared for … pediatric populations. It has included work on precision medicine and genomic technology -- promising scientific tools … and Drugs, NCTR 50th Anniversary Celebration … Animal & Veterinary … Biologics … Cosmetics … Dietary Supplements … …
FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease
… said Charles Ganley, M.D., director of Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research. “While there are FDA … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA In Brief: FDA issues draft guidance to foster oncology product development for pediatric populations
… FDA: Office of Oncologic Diseases FDA: Oncology Center of Excellence FDA: Pediatric Oncology The FDA, an … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA updates warnings for fluoroquinolone antibiotics
https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics
… of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that … assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for …
FDA In Brief: FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants
… concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Drug developers … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies
… of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “With today’s … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA In Brief: FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health
… director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research: “Today, the U.S. … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
… -director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug … Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. … the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for …
2020 at FDA: A Year of Unparalleled Contributions to Public Health
… E. coli, the 2020 Leafy Greens STEC Action Plan . Our Center for Food Safety and Applied Nutrition launched two new … engineered foods, commonly called GMOs. Our Center for Veterinary Medicine (CVM) made history this month with the approval of …
FDA approves first treatment for all genotypes of hepatitis C in pediatric patients
… of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA’s Budget: Data Modernization and Enhanced Technologies
… Business Issues Historically, the FDA has taken a center-based approach to IT investments, resulting in siloed … million above the FY 2021 enacted level for the Center for Veterinary Medicine (CVM) to modernize outdated and disparate IT systems …
FDA approves first oral GLP-1 treatment for type 2 diabetes
… of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Before this … that Rybelsus is not recommended as the first choice of medicine for treating diabetes. Patients who have ever had … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Remarks by FDA Acting Commissioner Janet Woodcock to the FDLI Annual Conference - 05/18/2021
… use, and • One COVID-19 treatment approved by the FDA Our Center for Devices and Radiological Health has issued more … recall of more than 170 such products. Our Center for Veterinary Medicine warned consumers about certain veterinary products, …
FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients
… of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. “Mirabegron, the … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …