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 Senate Health, Education, Labor and Pensions (HELP) Committee has advanced reauthorization of the 2006 Pandemic and All Hazards Preparedness Act (PAHPA), allowing the FDA to require that manufacturers notify the agency of potential product shortages when there’s no public health emergency (PHE). Read More
In an open public meeting, the FTC voted 3-0 Thursday to withdraw comments it has issued over the past 13 years in support of pharmacy benefit managers (PBM) – comments the PBM industry has begun using to defend itself in recent public relations campaigns. Read More
Boehringer-Ingelheim, Eli Lilly and Novo Nordisk have added their support to a bipartisan, bicameral bill — the Treat and Reduce Obesity Act (S. 2407 and H.R. 4818) — to expand Medicare coverage of medications and health care specialists to treat obesity. Read More
The letter points out that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients are from India and China. Read More
Bufferin, a brand synonymous with aspirin for many consumers, features in a head-scratcher FDA action as the agency withdraws the product’s 1948 NDA because the named manufacturer has failed to file required multiple annual reports on the prescription drug, which hasn’t been marketed for years. Read More
A tornado with winds of 150 mph slammed into Pfizer’s enormous drug manufacturing plant in Nash County, N.C., on July 19, knocking out the facility that makes 25 percent of the company’s injectable medications. Read More
Five drugs that are likely to make the Inflation Reduction Act (IRA) price negotiation list accounted for 13 percent ($29 billion) of 2021 Medicare Part D spending, but were less than one percent of all covered drugs according to a Kaiser Family Foundation (KFF) analysis of the latest available sales data from CMS. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
Republican members of the House Energy and Commerce (E&C) Committee are pressing FDA Commissioner Robert Califf on the effectiveness of the agency’s foreign drug inspection program given that numerous Indian and Chinese firms have repeatedly flouted FDA regulations. Read More