Quality Systems

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

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.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

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

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company’s laboratory and equipment.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.

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

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

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.

Pharmaceutical manufacturers and business partners are studying how Advanced Digital Ledger Technology might solve supply chain and other data transfer problems.

The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

Efforts to accelerate drug development will alter fee structure and require ready production sites.

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.