Quality/GMPs

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

An increase in applications for gene therapies is putting stress on FDA’s resources.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

The agency has published guidance on good practices for securing the supply of medicines.

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.

Batch-to-batch variability and impurities present critical challenges.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.