Quality/GMPs

A new study in NEJM compares the regulatory review processes of FDA and EMA.

Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.

EMA has developed a framework and action plan to foster relationships with the academic community.

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.

Industry fears limited benefits as FDA readies voluntary data tracking program.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

The mAb is the first approved treatment that targets the progressive form of the disease.

The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.

A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.

Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.