Quality/GMPs

Stakeholders Seek Increased User Fee Support for Biologics

July 24, 2020

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

Drug Pricing Back in the Spotlight

July 21, 2020

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

Will FDA Inspections Ever Be the Same?

July 20, 2020

Industry should be seeking more information from FDA on how it will restart its current inspection program.

FDA Works to Resume On-site Domestic Inspections

July 13, 2020

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

FDA Maps Expectations for COVID Vaccine Proposals

July 09, 2020

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

Investigating an OOS in a Biosafety Cabinet

July 01, 2020

Determining the root cause of out-of-specification (OOS) and other problems requires a careful, deductive approach and a clear understanding of processes.

Minimizing Contamination During Biopharma R&D

July 01, 2020

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

FDA approves Roche’s Phesgo, a Fixed-Dose Combination Breast Cancer Drug

July 01, 2020

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

FDA Issues Complete Response Letter to Allergan, Molecular Partners for Ocular Therapeutic BLA

July 01, 2020

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Analytical Assays Determine Biosimilar Product Quality

July 01, 2020

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.