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.
The Center for Drug Evaluation and Research (CDER) is set to reorganize its Office of Generic Drugs (OGD) to help keep up with the high volume of generic drug applications. Read More
The FDA is calling for risk assessments by cell and gene therapy (CGT) manufacturers to minimize the potential for transmitting the SARS-CoV-2 virus through their products, according to a new straight-to-final guidance released yesterday. Read More
The FDA called on drug compounders to know their active pharmaceutical ingredient (API) suppliers as it issued a warning letter to Houston, Texas-based Professional Compounding Centers of America (PCCA) for using a supplier whose drug ingredients had been placed on an import alert. Read More
Yuyao YiJia Daily Chemical, an over-the-counter drug manufacturer in Ningbo, China, drew a warning letter from the FDA for not adequately testing its products, their active ingredients and the raw materials used to manufacture them. Read More
The FDA issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has released its list of planned new and revised guidances for calendar year 2021, an agenda that includes a large number of generic drug-related topics. Read More
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More
FDA has published two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Read More
FDA inspections revealed good manufacturing practice and other deficiencies at drug manufacturing facilities in New Jersey, Vermont and California, leading to Form 483 inspection observations for four firms. Read More