Regulatory Oversight and Compliance

FDA and EMA set up new working group on the development of treatments for rare diseases.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

NICE estimates asfotase alfa will cost £367,000 per patient per year.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

The agency has recommended marketing authorization for Ibrance in the European Union.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.

Industry experts discuss recent trends in modular manufacturing.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

FDA found no observations during recent inspection of Regis Technologies manufacturing site.