Quality Systems

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Reliable, high-quality products require innovative analytics and production.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.

Covert and layered approaches to combat drug counterfeiting and illegal diversion strive to stay ahead of criminal enterprises.

Governments stretch limited resources to track counterfeit, diverted, and stolen pharmaceuticals globally. \

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

The biosimilar pathway permits licensure based on less than full clinical data.

The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating.

TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.

Douglas C. Throckmorton, MD, provides some key facts about abuse-deterrent opioids.

US and Chinese pharmacopeial standards groups commit to collaboration on standards for drug safety.

Consider the purity of exhaust air emitted by vacuum pumps in addition to the purity of compressed air used in the pharmaceutical process.

The Czech Republic drug manufacturer was cited for data integrity and quality issues.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

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.