Quality/GMPs

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

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

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.

The company is voluntarily recalling product due to particulate matter.

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.

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

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 company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

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.

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

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

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

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.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

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

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.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

The company was cited by FDA for violations of sterile processing GMPs.

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.

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