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Latest posts
Last updated about 3 hours ago
Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence
about 4 hours ago
As defined by FDA, real-world data (RWD) are the data relating to...
Real-World Evidence
about 4 hours ago
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in...
Drug Trials Snapshots: SOFDRA
about 4 hours ago
SOFDRA is an anticholinergic antiperspirant approved for primary axillary hyperhidrosis in adult...
Novel Drug Approvals for 2022
about 5 hours ago
Innovative drugs often mean new treatment options for patients and advances in...
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
about 22 hours ago
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance...
Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination
about 23 hours ago
September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1)...
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing
about 24 hours ago
Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A)...
FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination
1 day ago
FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals...
CDER Manual of Policies & Procedures | MAPP
1 day ago
CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation...
Submit Using eCTD
1 day ago
When submissions arrive in eCTD format, reviewers can easily find and access...
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
1 day ago
The following are the medical, statistical, and clinical pharmacology reviews of pediatric...
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2007-2012
1 day ago
In accordance with section 505A(k)(1) of the Act (Best Pharmaceuticals for Children...