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The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite the issue out of 18 overall warnings issued for quality violations as of late December. Read More
The Justice Department has charged two people with murder and 12 others with serious crimes over alleged manufacturing violations at the New England Compounding Center (NECC) that led to 64 deaths due to meningitis and sparked a federal law to rein in large compounders. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceutical imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform, regardless of port of entry. Read More
The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers. Read More
The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information. Read More
Generics makers are pressing the FDA to expand its criteria for granting first-generic status to ANDAs, a move that would put more drugs in line for expedited review. Read More
TWi Pharmaceuticals’ bid to market a generic version of Par Pharmaceutical’s AIDS drug Megace ES was dealt a major blow last month after a federal appeals court overturned a lower court’s ruling that had cleared the way for the product. Read More
The FDA’s proposal to survey pharmacists and patients on how changes to the physical appearance of a therapy may affect patient perceptions and drug adherence is raising concerns among both brand and generic drug manufacturers. Read More
A leaked draft of the Trans Pacific Partnership trade agreement gives far too much intellectual property protection to brand drugmakers at the cost of generic competition, GPhA says in a letter to the Obama administration. Read More
A federal judge has ordered Actavis to keep the original version of its blockbuster Alzheimer’s therapy Namenda on the market while the court hears an ongoing antitrust lawsuit that claims the drugmaker wants to pull the older version to hinder generic competition. Read More
Brand drugmakers in Europe are calling on the European Commission to implement a system to help resolve patent disputes before the launch of a generic drug, a move they say would address inefficiencies in the current patent litigation system. Read More