Regulatory Oversight

The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.

The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

A number of organizations have analyzed and estimated the size of pharma’s counterfeit and diversion problem.

As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

The agency has recommended marketing authorization for Ibrance in the European Union.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.

Industry experts discuss recent trends in modular manufacturing.

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

FDA found no observations during recent inspection of Regis Technologies manufacturing site.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

The Chinese facility was cited for data integrity violations.

The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.