Regulatory Oversight and Compliance

Drug Shortages Continue to Plague FDA and Manufacturers

July 02, 2023

Problems continue despite actions by regulators to better prevent and address drug shortages.

The Inspection Result: Warning Letters and Form 483s

July 02, 2023

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

Drug Pricing’s Static Changes

July 02, 2023

The debate surrounding drug pricing changes rages on.

FDA Approves UCB Generalized Myasthenia Gravis Treatment

June 30, 2023

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

FDA Approves Pfizer Human Growth Hormone Analog

June 29, 2023

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

NCI Launches Persistent Poverty Initiative

June 29, 2023

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA

June 27, 2023

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

FDA Releases Psychedelic Drugs Draft Guidance

June 26, 2023

FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.

FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act

June 23, 2023

The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

FDA Releases Updated COVID-19 Vaccine Guidelines

June 21, 2023

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.