The FDA cited Milbar Laboratories, an OTC drug manufacturer based in East Haven, Connecticut, for repeat inspection observations including failure to sterilize a purified water system. Source: Drug Industry Daily

The Pharmaceutical Care Management Association is concerned about a proposed rule that could remove safe harbor protections for pharmaceutical company rebates and significantly change how drug prices are formulated. Source:…

The FDA released new ICH guidelines designed to help researchers navigate the sometimes conflicting regional requirements and differences in global clinical trials. Source: Drug Industry Daily

The FDA on Friday published 26 new product-specific draft guidances for generic drug trials and 17 revisions, saying it hopes to broaden access and help cheaper drugs get to market…

Minneapolis, Minnesota-based Fairview Compounding Pharmacy was hit with a Form 483 after an FDA inspection in April revealed serious sterilization deficiencies. Source: Drug Industry Daily

The FDA issued a warning to bB Biochem Laboratories for unsupported product expiration dates, a failure to test incoming raw materials and for having no quality unit. Source: Drug Industry…

FDA Commissioner Scott Gottlieb announced Thursday that the agency will consider allowing imports of some drugs that have seen major price increases in the United States. Source: Drug Industry Daily

CDER Director Janet Woodcock released details of a major overhaul of four CDER offices Thursday aimed at improving the center’s ability to respond to new priorities. Source: Drug Industry Daily

The FDA released draft guidance on field alert reports, using a Q&A format to outline the responsibilities of drug applicants for FAR submissions. Source: Drug Industry Daily

Drug sponsors and investigators should work with organizations that offer either interoperable or integrated electronic health records or electronic data capture systems, the FDA said in a final guidance released…