Years of legal wrangling came to a close with Allergan agreeing to a $13 million settlement for claims the company illegally promoted eye drugs by providing consulting and other services…

A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Source:…

The European Medicines Agency and the European Network for Health Technology Assessment have developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments…

Following the U.S. Supreme Court’s defining decision on the biosimilar “patent dance” and approval process, Sandoz has requested that an unresolved part of its case against Amgen return to a…

The FDA and the European Medicines Agency released a draft joint plan Monday to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can…

Three unapproved ingredients and a host of labeling and other GMP violations have resulted in an FDA warning letter for a Texas-based supplement company. Source: Drug Industry Daily

The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Source: Drug Industry…

A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no…

The European Commission updated its 2011 action plan against antimicrobial resistance, pledging to boost research into new treatments and develop guidelines for the prudent use of the drugs. Source: Drug…

To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a…