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The FDA is seeking input on how it can make its Inactive Ingredients Database more useful and user-friendly, following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More
Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during an Aug. 24 public meeting on the draft document. Read More
The FDA is amending its color additive regulations to allow for the use of spirulina extract in coating formulations for drug tablets and capsules — giving drugmakers an alternative blue color that is exempt from safety certification requirements. Read More
CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff. Read More
A drug pricing watchdog was rebuffed on Aug. 25 in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More
The FDA released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released Sunday. Read More
As Zarxio’s Sept. 3 launch date nears, Sandoz is urging the Federal Circuit to dismiss Amgen’s last-ditch effort to block the Neupogen biosimilar, saying the brandmaker’s request for an emergency injunction doesn’t meet the required standard. Read More
The PTAB found Acorda’s mention of the posters in information disclosure statements didn’t constitute an admission that the posters were printed publications. Read More