Regulatory Authority Actions

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

Hillary Clinton unveiled a new plan on Sept. 22 during a community forum in Des Moines, Iowa to tackle high drug prices. The plan reveal was a follow-up to a tweet from the presidential candidate a day prior, on Sept.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Manufacturers challenge details in new policies designed to promote access to important therapies.

FDA publishes the final Q3D Elemental Impurities guidance.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

FDA and industry support global framework and collaborations to secure the supply chain.

This article discusses cleaning validation of equipment dedicated to the production of a single API.