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December 2018

No. 317


Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

FDA Moves to Modernize Inspections for Sterile Injectables

The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions. Read More

EMA Invites Comments on Water Quality Guideline for Drugmakers

The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use. Read More

Former Genentech Employees Charged With Theft of Trade Secrets

Three former Genentech employees were indicted by a federal grand jury for allegedly stealing trade secrets from the San Francisco-based Roche subsidiary, which is pursuing litigation of its own against the ex-staffers. Read More

Warning Letter Roundup: FDA Warns Five Firms Over CGMPs

The FDA issued warnings to five drug manufacturing facilities for numerous CGMP deficiencies and other issues. Read More

AAM Questions FDA’s Product Identifiers in Supply Chain Guidance

Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Read More

FDA Turns Down Testosterone Pellet Petition

The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it. Read More

483 Roundup: FDA Flags Eight Firms for Quality Issues

The FDA cited eight drugmakers for a variety of quality and other violations observed during agency inspections. Read More

Hetero Sued for Valsartan Contamination

A federal lawsuit filed in Massachusetts claims Indian generic drugmaker Hetero and its U.S. subsidiary Camber Pharmaceuticals ignored warning signs that the blood-pressure drug valsartan was contaminated and continued to supply it in the United States. Read More