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.Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence - 04/25/2024
Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 25, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: March 22, 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 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Rationale for Piperacillin Tazobactam Breakpoints for Pseudomonas aeruginosa
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Ceftazidime – Injection products
; Exceptions to the recognized standard of CLSI M100 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Trials Snapshots: POMBILITI
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
The FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 21, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 21, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They Contain Undeclared Prescription Drugs Including Sildenafil (Viagra) and/or Tadalafil (Cialis)
Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act RIA (Proposed Rule)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: March 19, 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 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
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
