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Drugs by FDA

What’s New: Drugs RSS Feed

  • What’s New Related to Drugs
    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.

  • Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information
    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

  • CDER Small Business and Industry Assistance (SBIA) Learn
    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.

  • FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer
    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.

  • Topical Dermatologic Corticosteroids: in Vivo Bioequivalence
    by FDA on April 13, 2021 at 6:25 pm

    Biopharmaceutics

  • Generic Drug Research Collaboration Opportunities
    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.

  • FDA Study Data Technical Rejection Criteria (TRC): What you need to know! – 05/21/2021 – 05/21/2021
    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.

  • Generic Drug Facilities, Sites and Organization Lists
    by FDA on April 13, 2021 at 6:14 pm

    Generic Drug Facilities, Sites and Organization Lists

  • Hematology/Oncology (Cancer) Approvals & Safety Notifications
    by FDA on April 13, 2021 at 6:12 pm

    Hematology/Oncology (Cancer) Approvals & Safety Notifications

  • La FDA advierte que el abuso y el uso indebido del descongestionante nasal propilhexedrina causan graves daños
    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.

  • Coronavirus (COVID-19) Update: April 13, 2021
    by FDA on April 13, 2021 at 5:31 pm

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

  • PDUFA VII: Fiscal Years 2023 – 2027
    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.

  • FDA and Health Canada Regional ICH Consultation – 05/14/2021 – 05/14/2021
    by FDA on April 13, 2021 at 3:40 pm

    Meeting

  • Cardiovascular and Renal Drugs Advisory Committee Roster
    by FDA on April 13, 2021 at 3:39 pm

    Advisory Committees (Drugs)

  • Biosimilar User Fee Amendments
    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.

  • Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
    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.

  • FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm
    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.

  • A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling
    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

  • Mifeprex (mifepristone) Information
    by FDA on April 13, 2021 at 1:36 pm

    Mifeprex (mifepristone) Information

  • MYM Hidrominerales S.A. de C.V. – 610066 – 04/09/2021
    by FDA on April 13, 2021 at 1:20 pm

    Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

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