Quality Systems

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

Articles

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA Resumes In-Person Meetings with Industry … Sort Of

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

FDA Seeks to Simplify COVID-19 Vaccination Program

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

FDA Releases Research Roadmap for Biosimilars Pilot Program

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

FDA Issues Guidance on Development of Drugs for Monkeypox

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability. 

AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor

The guidance provides examples of required and recommended information in the Dosage and Administration section.

FDA Publishes Guidance on Labeling Drugs and Biological Products 

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

FDA Signs Mutual Recognition Agreement with Swiss Confederation

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Pharmacovigilance Risk Assessment Committee Meeting Highlights

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Regulatory Authority Actions