We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
European officials cited Indian API maker Dishman Carbogen Amcis for serous quality failures found during an inspection of its facility in Gujarat. Read More
An FDA investigator found lapses in good manufacturing practices in an inspection of Time-Cap Laboratories’ drug manufacturing and repackaging facility in Farmingdale, New York. Read More
The FDA cited active pharmaceutical ingredient (API) manufacturer Abbey Color for failing to properly qualify its suppliers and other quality lapses at its Philadelphia, PA facility. Read More
The FDA issued warning letters to two drugmakers and two contract testing facilities for serious quality failures, including testing violations, data integrity lapses and lax environmental monitoring. Read More
The FDA is working with the Centers for Disease Control and Prevention (CDC) to determine how it will restart routine on-site inspections of drug manufacturing facilities, the agency announced. Read More
Following considerable public outcry over potential conflicts of interest for government officials who are working on the Trump administration’s initiative to develop COVID-19 treatments and vaccines, Janet Woodcock is temporarily stepping down as director of the Center for Drug Evaluation and Research (CDER). Read More
Among the many urgent priorities it faces during the pandemic, the FDA is devoting substantial resources to monitoring fraudulent COVID-19 products, issuing two dozen warning letters in May — including, for the first time, one to a company selling a fake vaccine. Read More
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance exempting certain COVID-19 products from tracing and identification requirements. Read More
CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP). Read More
The FDA hit online pharmacy Unitedpharmacies.md with a warning letter for marketing on its website unapproved and misbranded products as COVID-19 treatments. Read More