by FDA on April 13, 2021 at 7:56 pm

Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

by FDA on April 13, 2021 at 6:51 pm

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians

by FDA on April 13, 2021 at 6:43 pm

SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry.

by FDA on April 13, 2021 at 6:31 pm

FDA granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.

by FDA on April 13, 2021 at 6:25 pm

Biopharmaceutics

by FDA on April 13, 2021 at 6:19 pm

The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.

by FDA on April 13, 2021 at 6:15 pm

FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations.

by FDA on April 13, 2021 at 6:14 pm

Generic Drug Facilities, Sites and Organization Lists

by FDA on April 13, 2021 at 6:12 pm

Hematology/Oncology (Cancer) Approvals & Safety Notifications

by FDA on April 13, 2021 at 5:32 pm

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de EE. UU. advierte que el abuso y el uso indebido del descongestionante nasal propilhexedrina, de venta libre (OTC, por sus siglas en inglés), pueden provocar graves daños, incluidos problemas cardíacos y de salud mental.

by FDA on April 13, 2021 at 5:31 pm

Coronavirus (COVID-19) Update: April 13, 2021

by FDA on April 13, 2021 at 4:45 pm

Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.

by FDA on April 13, 2021 at 3:40 pm

Meeting

by FDA on April 13, 2021 at 3:39 pm

Advisory Committees (Drugs)

by FDA on April 13, 2021 at 3:27 pm

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022.

by FDA on April 13, 2021 at 3:15 pm

The Drug Information Soundcast in Clinical Oncology (DISCO) communicates key regulatory and safety aspects of oncology and hematology new drug approvals to the practicing oncologist, as well as other health care providers, consumers, pharmacists, and patient advocates in a concise and easily digestible format.

by FDA on April 13, 2021 at 2:38 pm

FDA warns that abuse and misuse of the over-the-counter nasal decongestant propylhexedrine causes serious heart and mental health problems, disability or death. Only use propylhexedrine according to the directions on the Drug Facts label.

by FDA on April 13, 2021 at 1:54 pm

Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being con

by FDA on April 13, 2021 at 1:36 pm

Mifeprex (mifepristone) Information

by FDA on April 13, 2021 at 1:20 pm

Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated