Generics-Regulatory Impact on Marketing

The number of Medicare Part D subscribers who fall into the coverage gap looks smaller than was feared. Will that fact fall into the gap inside the Beltway?

By going direct-to-consumer, the industry unwittingly unleashed a swarm of opportunities for other players to enter the pharmaceutical fray.

The Waxman-Hatch law is said to have given birth to the modern generic drug industry in the United States

All approved drugs, both innovator and generic, are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Dynamic Changes Require Informed Decision Making

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product

Issue of the Case ...Facts of the Case ...The Court's Ruling...The Court's Reasoning

Ever wonder how all those biotechs, specialty shops, and generics that make up Not Big Pharma ever manage to stay in business?

PDUFA provides user fee funds, paid by brand drug and biotechnology companies that are added to appropriated funds to support the review of new human drugs

Financial ties to drug companies may bar experts from advising agency