Regulatory Authority Actions

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

A new report gives an overview of the work of the International API Inspection Program.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.

The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.