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.Benefits of Emerging Technology Program
CDER ’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
News from Emerging Technology Program (ETP)
CDER ’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Remarks by FDA Commissioner Robert M. Califf to the Coalition for Health AI (CHAI) - 03/05/2024
Remarks by Robert M Califf MD
Commissioner of Food and Drugs
The Coalition for Health AI (CHAI)
March 5, 2024 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Cosmetic Specialty Labs, Inc. - 671239 - 02/29/2024
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 - March 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Bell International Laboratories, Inc. - 669736 - 02/15/2024
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 - March 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
ivsupplyclinic.com - 672780 - 02/09/2024
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: March 1, 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 - March 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications
On March 1, 2024, the FDAapproved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Works to Make Informed Consent Easier to Understand
FDA and the Office for Human Research Protections have published a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.” (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
QUICK Rheumatism Capsule, Tiger Wang Biaod contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use QUICK Rheumatism Capsule, Tiger Wang Biaod, a product promoted and sold for rheumatism on various websites 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 - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
SNAKE BONES Anti-Rheumatic Capsules contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use SNAKE BONES Anti-Rheumatic Capsules, a product promoted and sold for rheumatism on various websites 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 - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Helps to Deliver Meaningful Advances for Rare Disease Patients
We remain committed to supporting rare disease research, engaging patients and caregivers to understand their unique perspectives, and enhancing our review processes to advance medical products for rare disease patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Natural History Studies and Registries in the Development of Rare Disease Treatments - 05/13/2024
Natural History Studies and Registries in the Development of Rare Disease Treatments (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
