Quality Systems

Articles

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Digital Health Technologies Document Outlines Framework for FDA

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation. 

First Drugs Hit by Inflation Reduction Act Price Controls

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability. 

FDA Seeks $7.2 Billion to Protect and Advance Public Health

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Congress Probes PBM Link to Higher Drug Prices

Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.

Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone 

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% 

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle. 

FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Regulatory Authority Actions