Regulatory Authority Actions

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.

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.