Quality/GMPs

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.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.

Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

President Trump calls for faster FDA approvals and lower drug prices.

Drug type, potential sales, and ownership factor in the race to get drugs to market.

Manufacturers face uncertainty over imports, regulatory policies, and field inspections.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

Moving global manufacturing operations may be more complicated than it appears.

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.