August 8th 2024
Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
Drug Industry Criticizes Patent Settlement Provisions in House Spending Bill
July 8th 2010The US House of Representatives passed on July 1, 2010, HR 4899, the Supplemental Appropriations Act of 2010, which included provisions restricting patent settlements between innovator-drug and generic-drug companies, a move that drew criticism from both sectors of the pharmaceutical industry.
USP Opens Door to Pending Monographs for Excipients
May 13th 2010Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.
SOCMA Issues API Quality-Agreement Template
May 13th 2010In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.