The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft. Source:…
Problems with handling complaints, maintaining sterile production conditions and following up on testing crop up in reports of on-site inspections. Source: Drug GMP Report
Makers of APIs, compounded drugs, and dietary supplements draw warnings from the agency for a variety of GMP and other violations. Source: Drug GMP Report
The FDA updated its staff manual on Chemistry, Manufacturing and Controls reviews of drug master files for packaging materials. Source: Drug GMP Report
The European Medicines Agency’s pharmacovigilance panel made recommendations for updated label warnings for a variety of products. Source: Drug GMP Report
During the presidential campaign of 2015-2016, one of the areas that got some of the largest scrutiny was drug pricing, and with good reason. Source: BioSpace
Pfizer is planning to hire 200 new staffers and another 200 replacement workers in Michigan. Source: BioSpace
The investment is not part of Gates’ philanthropic Bill & Melinda Gates Foundation and will be followed with another $50 million in a number of start-up ventures working in Alzheimer’s…
After falling short of analysts' expectations in its latest quarter, Novo Nordisk is restructuring its commercial operations as it looks to fend off challenges to its products. Source: BioSpace
The initial results were presented at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Source: BioSpace