Should the FDA get the 11 percent increase in funding that it’s gunning for from Congress, a large chunk will be spent improving internal data quality at the agency, said…
The legal fight around the Inflation Reduction Act’s (IRA) drug price negotiation policy continues as the AARP and Public Citizen have submitted amicus briefs supporting the law and Boehringer Ingelheim…
Philips has issued an urgent field safety notice for certain of its imaging systems for a potentially faulty foot switch that may lead to unintended radiation. Source: Drug Industry Daily
The Department of Justice (DOJ) has resolved criminal antitrust charges against Teva Pharmaceuticals and Glenmark Pharmaceuticals for price fixing with deferred prosecution agreements, hefty fines, admission that the DOJ’s facts…
Ten years and $2.5 billion — that’s what it takes, on average, to bring a new drug to market in the United States. Artificial intelligence (AI) promises to supercharge this…
The FDA has issued multiple draft and revised product-specific guidances that provide recommendations on the design of bioequivalence studies to support ANDAs and facilitate generic drug product availability. Source: Drug…
After suffering the setback of a complete response letter (CRL) concerning its contract manufacturing plant, Regeneron has bounced back with FDA approval of two drugs — Eylea HD (aflibercept 8…
Krystal Biotech is offloading its priority review voucher (PRV) for a cool $100 million to an undisclosed buyer, a practice that nets companies cash — in highly variable amounts. Source:…
The FDA’s Circulatory System Devices Panel will review premarket applications for two investigational renal denervation devices this week, both designed to help control refractory hypertension by ablating some of the…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily