Regulatory/GMP Compliance

FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.

A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.

The multitude of health reform measures emerging on Capitol Hill has accelerated lobbying action across the board, along with campaign donations to candidates from all sides.

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.

Industry and regulators seek global system that reduces regional differences.

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.

Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

New tools and policies aim to support more complex manufacturing processes.

FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.