Industry News

FDA’s inactive ingredients database (IID) has been under development for several years, as a way to allow generic and name-brand pharmaceutical manufacturers to check on the safety and performance of specific inactive ingredients.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

USP responds to FDA's draft guidance on the naming of biological products.

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

Rx-360 announced that Mark S. Paxton has been appointed as the new chief executive office of the international pharmaceutical supply chain consortium. This appointment follows the successful growth of Rx-360 since its foundation in 2009 in the aftermath of the adulterated heparin tragedy. Rx-360 has 300 volunteers from more than 100 institutions that are organized in 17 working groups with activities in the US, Europe, China, and India.

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

Eight researchers are honored at the 2015 AAPS annual meeting for contributions to the pharmaceutical sciences.

Association recognizes top scientists and students at the annual meeting for research achievements.

Bottles of the affected lot were marked with a lower strength of 325 mg instead of 500 mg and pose a risk of drug overdose that can lead to liver toxicity or liver failure.

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.

Impax Laboratories announced that FDA has approved its generic version of guanfacine extended-release tablets 1 mg, 2 mg, 3 mg, and 4 mg.

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

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

In the past, contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) have been focused most on achieving scale, reaching new clients in new geographic regions, and adding services that were previously unavailable, according to Gil Y. Roth, president of the Pharma and Biopharma Outsourcing Association. In a new report from CPhI, Roth explicates how consolidation has changed how CMOs position their services to clients and how CMOs add value to their businesses.

The European Medicines Agency plans on using existing patient registries to collect information on medicines.

Biogen, Sobi, and the World Federation of Hemophilia collaborated to enable a sustained humanitarian supply of hemophilia treatment to developing countries, and the first shipments have begun to arrive.

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

Through the Glycoscience Program, the National Institute of Health will contribute $10 million to advance the study of carbohydrates and the compounds that interact with them.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

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.

Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

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.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

Stephen J. Ubl to succeed John J. Castellani as the next president and chief executive officer of PhRMA.