09.29.2020

January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)
09.29.2020

FDA clarifies compounding policies

FDA has received questions and feedback on several of its current policies and is providing the following information to stakeholders to clarify its current thinking. FDA is reviewing the complex issues raised in these comments and taking them into consideration as the agency works to update, revise
09.29.2020

FDA Drug Topics: Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information – October 27, 2020

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians
09.29.2020

Generic Drug Facilities, Sites and Organization Lists

Generic Drug Facilities, Sites and Organization Lists
09.29.2020

Roche's $1.5B Tamiflu stockpiling lawsuit drags on as U.S. judge allows case to proceed

Roche's $1.5B Tamiflu stockpiling lawsuit drags on as U.S. judge allows case to proceed aliu Tue, 09/29/2020 - 10:54
09.29.2020

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) due to lack of sterility assurance.
09.29.2020

FDA Voices on Policy

FDA Voices on Policy
09.29.2020

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical in
09.29.2020

Competitive Generic Therapy Approvals

A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act.
09.29.2020

FDA Voices

Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.