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 needs to investigate the drug industry’s replacement of the active ingredient in certain widely used nasal decongestants to make sure these products are effective, Rep. Henry Waxman (D-Calif.) said in an Aug. 23 letter to the agency.
Pharmaceutical manufacturers, skittish about implementing the FDA’s suggested quality system changes to current good manufacturing practices (cGMPs) until they get more information, have been hoping for more clarity from the agency.
U.S. generic firms should include more segments of the pharmaceutical manufacturing and marketing process if they hope to compete globally, said one pharmaceutical finance expert at a recent industry conference.
Senior pharmaceutical executives must play a more active role in overseeing GMP initiatives under the FDA’s new approach to risk management, according to an industry expert who urged firms to start applying quality manufacturing concepts earlier in the drug development process.
The FDA is expected soon to release its long-awaited list of priorities for changing the drug development process, pending agreements between the agency, the NIH and academics, says a high-ranking FDA official.
A series of FDA guidances, released Jan. 18, aim to help drugmakers comply with the agency's final rule on labeling of human prescription drugs and biologic products.
Pharmaceutical manufacturers will have to implement some of the most sweeping changes to their drug labeling in a generation under a new FDA rule that aims to provide greater clarity to Rx labeling information.
The FDA has released a series of guidances and a final rule aimed at speeding products to market by streamlining the investigational new drug (IND) application process.
Standards setting body ASTM International has established a pharmaceutical standards subcommittee that will address issues of quality within a broad framework of chemistry, manufacturing and control.