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The FDA issued an advisory to drugmakers about the risk of bacterial contamination of non-sterile water-based drug products by Burkholderia cepacian (BCC). Read More
The FDA sent a warning letter to Round Rock, Texas-based Davati Medical Supply instructing it to stop marketing an unapproved quadrivalent influenza vaccine. Read More
The FDA added some clarifications in a final guidance for sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on submitting field alert reports (FARs), reminding them that FAR requirements apply to all products under an NDA or ANDA including positron emission tomography drugs, designated medical gases, and combination products containing a drug constituent part. Read More
The FDA explained in a new Manual of Policies and Procedures (MAPP) how generic drug sponsors can get their applications approved even if the submission coincides with labeling changes to the reference drug. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new quality guideline for sponsors of drug-device combination products that will go into effect on Jan. 1. Read More
The House Energy and Commerce Committee wants Acting FDA Commissioner Janet Woodcock to explain how the agency plans to address the backlog of nearly 8,000 inspections accumulated during the pandemic as lawmakers worry about the potential impact on the agency’s drug reviews. Read More
The FDA is taking an “all-hands-on-deck” approach to swiftly give full approval to the Pfizer-BioNTech COVID-19 vaccine, an agency spokesperson said Friday. Read More
The FDA has revised the Risk and Evaluation and Mitigation Strategy (REMS) for the generic anti-psychotic drug clozapine in an effort to improve patient monitoring for the rare blood disorder neutropenia. Read More
Remi Barbier, CEO and founder of Cassava Sciences, has gone on the defensive after independent scientists called into question the positive preliminary results of the company’s small Alzheimer’s drug study. Read More
The FDA has issued a second noncompliance letter to Georgia-based biopharmaceutical firm Accuitis for failing to submit clinical trial results to the National Institutes of Health’s ClinicalTrials.gov data bank. Read More