Regulatory Authority Actions

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

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.

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.

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.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

FDA plans to initiate its quality metrics program as industry continues to push back.

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

In a press release, Momenta announced on Feb. 16, 2017 that Momenta/Sandoz’s fill/finish contract manufacturer, Pfizer, received a warning letter for the manufacture of the 40 mg of Glatopa (glatiramer acetate injection), Momenta’s generic version of the drug Copaxone. Pfizer said in the statement that the warning letter does not affect the production or shipment of the 20 mg version of the drug, which is already approved by FDA.

The regulatory agency rejected the medication, citing various issues related to device use.

The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.

FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

Reducing regulatory roadblocks requires more than the stroke of a pen.

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.