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.
More than two dozen lawmakers signed onto a letter pressing the FDA on what steps it is taking to “minimize the potential for disruptions to supply and patient care” as deadline for implementation of the DSCSA nears. Read More
The FDA and the European Medicines Agency (EMA) have both issued guidances on various aspects of detecting, measuring, limiting and avoiding the presence of nitrosamine impurities in pharmaceuticals. Read More
LXR Biotech received a warning letter from the FDA for having methods, facilities, controls for manufacturing, processing or holding its drug product that do not conform to GMPs, after the company’s response to a Form 483 included a statement that it no longer manufactures drugs. Read More
The FDA has released a final guidance spelling out when and how drugmakers may seek a waiver, exception or exemption from its regulations as permitted by the Drug Supply Chain Security Act (DSCSA) while a bipartisan group of House lawmakers is pressing the FDA on whether the industry is prepared for the final stage of the act’s implementation. Read More
Savings to the federal government from minimum discounts will only accrue to $1.8 billion against Congressional Budget Office’s estimate of $3.7 billion in the upcoming implementation of the drug savings elements of the Inflation Reduction Act (IRA), according to a recent study published in the Journal of Managed Care + Specialty Pharmacy. Read More
Improving FDA advisory committee procedures and combatting misinformation are two important goals for FDA’s Chief Scientist Namandjé N. Bumpus who shared some insights from her first year of work during an informational “fireside chat” sponsored by the Alliance for a Stronger FDA on Wednesday. Read More
A new draft guidance focuses on obtaining tentative approval — granted for drugs that cannot be marketed in the U.S. because of existing patents or exclusivity — for various HIV treatment and prevention drugs intended for distribution outside the U.S. under the President’s Emergency Plan for AIDS Relief (PEPFAR). Read More
The FDA and the Drug Enforcement Agency (DEA) have asked manufacturers to confirm they are working to increase production of their allotted quota of ADHD drugs to help resolve shortages. Read More
Comments from numerous stakeholders have sounded the alarm over the lack of detail on oversight/responsibility for remote vendors and a new“task log” in the FDA’s draft guidance on decentralized trials (DCT). Read More