05.07.2021

Novo Nordisk recalls sales rep samples sunk by Texas power outages

Novo Nordisk recalls sales rep samples sunk by Texas power outages bbulik Fri, 05/07/2021 - 18:18
05.07.2021

Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results

Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level. The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stabili
05.07.2021

What's New Related to Drugs

Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
05.07.2021

Pfizer, Merck KGaA's Bavencio hits NICE roadblock in bladder cancer coverage

Pfizer, Merck KGaA's Bavencio hits NICE roadblock in bladder cancer coverage aliu Fri, 05/07/2021 - 11:20
05.07.2021

Even with the pandemic in retreat, Amgen will let most employees keep working from home

Even with the pandemic in retreat, Amgen will let most employees keep working from home kdunleavy Fri, 05/07/2021 - 11:15
05.07.2021

Pfizer, AstraZeneca COVID vaccines probed in Europe after reports of heart inflammation, rare nerve disorder

Pfizer, AstraZeneca COVID vaccines probed in Europe after reports of heart inflammation, rare nerve disorder nhigginsdunn Fri, 05/07/2021 - 11:09
05.07.2021

Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

This page is a resource for ANDA Forms and Submission Requirements
05.07.2021

Phonetic and Orthographic Computer Analysis (POCA) Program

Use CDER’s Phonetic and Orthographic Computer Analysis (POCA) to help identify drug and biologic names that are phonetically and/or orthographically similar to one another. In conducting proprietary name reviews, the Division of Medication Error Prevention and Analysis (DMEPA) evaluates the orthographic and phonetic similarity of a proposed proprietary name to other proprietary or established names using the POCA software program. POCA uses algorithms to assess the similarity of names when spoken or written and assigns a percent similarity score to a given name pair.
05.07.2021

Ophthalmic Dosage Form Questions

Ophthalmic Dosage Form Questions
05.07.2021

Topical Dosage Form Questions

Topical Dosage Form Questions