Regulatory Authority Actions

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

The PRIME program is a drug development scheme to enable accelerated assessment of medications for conditions with unmet need.

The new committee will attempt to recruit regulatory professionals outside of existing ICH members to improve overall global pharmaceutical regulatory harmonization.

Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

The agency gives an update on the regulation of combination medical products.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

The agency releases guidance on controlled correspondences related to generic-drug development.

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.