A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

FDA Interactions with Industry Under Scrutiny

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

Crossing the Same River Multiple Times

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

Controlling Quality in Aging Facilities

Topic

Grant Playter is the Assistant Editor for 

Articles

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

FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials

 Washington Editor, jillwechsler7@gmail.com.

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 Eyes Advisory Committee Reform to Enhance Credibility

Feliza Mirasol is the science editor for 

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

FDA Approves Topical Gene Therapy for Treating Wounds Associated with Rare Genetic Skin Disorder

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

FDA Approves AbbVie’s Bispecific Antibody for Treating Lymphoma

Context surrounding the Inflation Reduction Act is necessary for a comprehensive understanding of the global biopharma market.

The United States and the Global BioPharma Market

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

FDA Grants Lumen Bioscience Fast Track Designation for Oral Biologic

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

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

FDA Sends Warning Letter to Arizona Facility

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best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

FDA Issues Guidance on Pediatric Drugs

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

EMA Issues Drug Safety Reminders

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

Quality/GMPs

FDA Interactions with Industry Under Scrutiny

Crossing the Same River Multiple Times

Controlling Quality in Aging Facilities