December 1st 2023
Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Halo Pharma Shows Fixed-Dose Combination Products are Effective for Simplified Dosing
April 6th 2018Anthony Qu, PhD, vice president of Scientific Affairs at Halo Pharma, will give a presentation on fixed-dose combination products, drug products containing multiple active ingredients, as an effective approach for simplified dosing at CPhI North America on Wednesday, April 25, 2018 in Philadelphia, PA.
FDA Highlights Responsibilities for Finished Biologics Manufacturers
August 21st 2007The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements.