Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
Facilitating Generic Drug Product Development through Product-Specific Guidances (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia
On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy f (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Skull Smash LLC - 672714 - 03/13/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CDER ’s Drug Quality Sampling and Testing Program
CDER ’s Office of Pharmaceutical Quality oversees the quality surveillance program using a targeted, risk-based approach to ensure the availability of safe, effective, quality drugs for the American public. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 18, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Remarks by Commissioner Robert M. Califf to the 2023 Global Summit on Regulatory Science - 09/26/2023
Remarks by Robert M. Califf, M.D. Commissioner of Food and Drugs 2023 Global Summit on Regulatory Science Sept. 26, 2023 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: March 15, 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 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

11th Annual Global Summit on Regulatory Science - 10/04/2021
Information about the Virtual 2021 Global Summit on Regulatory Science (GSRS21) - Title: 11th Annual Global Summit on Regulatory Science Conference (GSRS21); Theme: Regulatory Sciences for Food/Drug Safety with Real-World Data& Artificial Intelligence (AI); Question& Answer Sessions; October 4-6, 2021 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

PQRI Workshop:  Challenges and Opportunities for Modified Release Oral Drug Product Development - 04/18/2024
This PQRI Workshop will bring together leaders and subject matter experts from regulatory agencies, industry, and academia to discuss critical topics related to modified release (MR) drug products for oral administration. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Vi-Jon, LLC - 622087 - 03/08/2024
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 - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop - 04/16/2024
PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Quality, Current Good Manufacturing Practice Inspections and Compliance
Hospitals, health systems and patients rely on FDA to ensure the medications that are available are safe, effective and of high quality. For application products, typically prescription drugs, FDA ’s approval process is the first step. FDA’s drug application approval includes assessing the manufactur (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Announces New Quality Oversight Webpage
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease
The FDA approved the first medication for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring, to be used along with diet and exercise. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: COLUMVI
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Q & A with FDA Podcast
“Q&A with FDA ” is a monthly podcast series that provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news