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.FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 18, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Biosimilars Action Plan
FDA is committed to encouraging innovation and competition for biologics and facilitating the development of safe and effective biosimilars. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 18, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Pharmaceutical Inspections and Compliance
One way FDA works to ensure drug manufacturers comply with Current Good Manufacturing Practice (CGMP) requirements is through inspections. Learn more about actions that can be taken if manufacturers fail to meet CGMP regulatory standards. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 18, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information
FDA proposed a new type of Medication Guide known as Patient Medication Information (PMI). PMI is designed to provide concise, easy-to-understand information about prescription medicines for patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 18, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Ossos-Sans contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Ossos-Sans, a product promoted and sold for pain on various websites, including https://alnaturaleshop.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 17, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: April 16, 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 - April 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Trials Snapshots: VANFLYTA
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
C & T Dream Co., Ltd. - 678300 - 04/11/2024
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 - April 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Master Paints & Chemicals Corp. - 672462 - 03/13/2024
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 - April 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Natco Pharma Limited - 672564 - 04/08/2024
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 - April 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
What Is the Approval Process for Generic Drugs?
Overview of the FDA review and approval process for generic drugs (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Completed PDUFA VII Deliverables
Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Reflections on Travel to Europe – Part One
I recently had the privilege of official travel to the U.K. and European Union with our global affairs team. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
CDER Center for Clinical Trial Innovation (C3TI)
Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA establishes CDER Center for Clinical Trial Innovation (C3TI)
, which will promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
