Regulatory Oversight and Compliance

Quality Considerations for the Manufacture of Compounded Drugs

March 15, 2023

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

Overcoming Data Gaps in Pharmacovigilance

March 15, 2023

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.

Acadia Pharmaceuticals Receives FDA Approval for First Treatment for Rare Genetic Disorder

March 14, 2023

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

FDA Approves Pfizer’s New Migraine Nasal Spray

March 14, 2023

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.

FDA Seeks $7.2 Billion to Protect and Advance Public Health

March 14, 2023

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

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

March 10, 2023

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.

Congress Probes PBM Link to Higher Drug Prices

March 09, 2023

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

Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone

March 08, 2023

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.

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15%

March 06, 2023

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.

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

March 06, 2023

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