Regulatory Authority Actions

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

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

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.

The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.

The biosimilar pathway permits licensure based on less than full clinical data.

The Czech Republic drug manufacturer was cited for data integrity and quality issues.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Efforts to accelerate drug development will alter fee structure and require ready production sites.