Regulatory Authority Actions

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

The agency cited the Italian company for aseptic processing failures.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.

This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.

CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.

The agency announced a plan to eliminate its existing orphan designation request backlog.

The directorate highlights its 2016 achievements.

The agency announced it is taking steps to increase competition within the prescription drug market.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

Congressional measures lack the support to move forward.

The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.

FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.