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 FDA hit Blaine Labs with a lengthy Form 483 for a host of violations at its Santa Fe Springs, CA, facility, including repeated quality unit failures. Read More
The FDA published a final guidance over the weekend on compounding alcohol-based hand sanitizers and said the agency will not take regulatory action against outsourcing facilities for regulatory violations for such products provided they include certain ingredients. Read More
Eagle Pharmaceuticals prevailed in an appeals court ruling that the FDA can grant orphan drug exclusivity to multiple drugs for the same rare disease. Read More
The FDA detailed how sponsors can support the effectiveness of investigational new drugs or new drug uses for treatment of certain rare diseases, in final guidance published Friday. Read More
Former FDA Commissioner Scott Gottlieb said he believes a vaccine for COVID-19 — caused by a virus that could be “a once in a generation pathogen” — will take two years to become available for public use. Read More
The Trump administration’s plan for importing drugs from Canada will not result in lower prices for Americans, according to a slew of comments from drugmakers, industry groups and the Canadian government on the FDA’s proposed rule. Read More