FDA Center for Drug Evaluation and Research - What's New 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.Amman Pharmaceutical Industries - 668867 - 02/14/2024
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
LightEyez Limited - 665450 - 02/15/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Patient Medication Information (PMI)
FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide —"Patient Medication Information”—for prescription drug products used, dispensed, or administered on an outpatient basis (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Sichuan Deebio Pharmaceutical Co. Ltd. - 669808 - 02/05/2024
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment Due to Potential Lack of Sterility
Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food an (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Setting and Implementing Standards for Narrow Therapeutic Index Drugs
CDER's Narrow Therapeutic Index Drugs (NTI) working group works to resolve key NTI scientific and regulatory issues. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: February 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
WITHDRAWN: FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma
FDA announced its final decision to withdraw approval of melphalan flufenamide (Pepaxto) with dexamethasone to treat certain patients with multiple myeloma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)
FDA has announced its decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Biosimilars Guidances
This page lists Biosimilars Guidance documents. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Cefepime and Enmetazobactam Injection
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Trials Snapshots: JESDUVROQ
JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor that treats anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Science, Research, and Collaboration Advance Generic Medicines
In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Office of Generic Drugs 2023 Annual Report
Our 2023 Annual Report provides highlights of activities and accomplishments including generic drug approvals, first generic approvals, science and research innovations for generic medicines – including complex generics, and international collaboration. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Remarks by Dr. Califf to the 2024 Biannual Conference of the NYU Grossman School of Medicine Working Group on Compassionate Use and Preapproval Access - 01/30/2024
Speech by Robert M. Califf, M.D.
Commissioner of Food and Drugs
New York University School of Medicine
Biannual conference of the NYU Grossman School of Medicine Working Group on Compassionate Use and Preapproval Access
Jan. 30, 2024
New York City, NY (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
