"The Pink Sheet" – Most Notable Stories Of 2010
While industry mega-mergers occupied readers in 2009, the focus in 2010 shifted toward several evolving policy concerns and their impact on company strategy. Among these, more companies are looking at the opportunity for biosimilars created by the health care reform law's provision of a legal framework for product approval. But early analyses suggest that there is still a lot of work to do as FDA develops a guideline for industry on an abbreviated approval pathway.
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Waxman Says Biosimilar Pathway Will Push Applicants To BLA
The outgoing chairman of the House Energy and Commerce Committee said the new abbreviated biosimilar pathway FDA is now formulating likely will not attract many applicants.
For PhRMA, There Is Good News And Bad News In The Mid-Term Elections
The anti-government intervention sentiment coming to Congress in January with the newly elected Republicans presents a tactical challenge to lobbying efforts by the Pharmaceutical Research and Manufacturers of America.
FDA's Woodcock Expresses Concern Not All Generics Are Equivalent, But OGD May Have Solution
It didn't seem like deliberate choice to play good cop-bad cop, but Acting Office of Generic Drugs Director Keith Webber and Center for Drug Evaluation and Research Director Janet Woodcock offered a near textbook version of it at the recent Generic Pharmaceutical Association Fall Technical Conference.