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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
The FDA wants to make it easier for generics firms to acquire samples from brandmakers who claim drug safety protocols prevent them from selling the products for bioequivalence testing. Read More
Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product based on the actual amount of active ingredient in a dose rather than a proposed standard that compares dosages and routes of administration. Read More
GPhA is pushing for more states to pass automatic biosimilar substitution laws next year using draft language that eliminates requirements to notify prescribers of a swap with the brand. Read More