OR WAIT null SECS
August 02, 2018
More consistent and reliable production processes are critical for advancing innovative treatments.
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
August 01, 2018
Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
July 27, 2018
The recommended drugs include two orphan medicines and three biosimilars.
July 25, 2018
Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.
July 19, 2018
The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.