Quality/GMPs

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

Product labels should include more information on extrapolation, interchangeability, and the original source of clinical trial data, according to a survey of those in charge of dispensing medications.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

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

The PDA report discusses qualification and operational handling of passive thermal protection systems.

How can the industry achieve excellence when its training programs are geared to meeting minimum regulatory guidelines?

Rafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a

Dynamic light scattering techniques can monitor viruses and virus-like particles in their native state.

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.

US Compounding, Inc. issues voluntary recall of all sterile products.

A drug price hike like that of the one seen in the highly publicized case of Turing Pharmaceuticals' Daraprim is prompting a public outcry and is demonizing the industry for those who see Martin Shkreli as representative of all pharmaceutical executives. But capping drug price increases may affect actual patient costs less than imagined, and may have a bigger impact on pharmacy benefit managers and insurance companies.

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.

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.

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?

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

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

FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.

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.

China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

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.