Regulatory Oversight

China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.

Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.

ICH detailed the highlights of the council’s June 2016 meeting.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.

The two agencies have set up a working group on involving patients in drug development.

The agency provides quality, development, manufacturing, and labeling recommendations.

Computerized systems can solve some of the data integrity problems with conventional paper-based systems.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.

Pharma has voiced strong opposition against Britain’s departure from the EU.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.