Regulatory Oversight and Compliance

Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.

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

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

The warning letter cited GMP violations for finished drug products.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

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

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

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

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

The agency published an overview of marketing authorizations made in 2016.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

FDA published a flurry of guidance documents in late 2016.

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

The agency has published its refuse-to-receive standards guidance for abbreviated new drug applications.

The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.

The agency announces that 81 medicines overall were recommended in 2016.

FDA’s Center for Drug Evaluation and Research makes plans for implementation of the 21st Century Cures Act that include patient-focused drug development.

Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.

FDA issued a warning letter to Interquim, SA for CGMP deviations at its Barcelona API facility.

Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.

Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.

Republican control of Washington promises overhaul of healthcare and medical product regulation.