FDA Declared Support for a New AntioBiotic Pathway - Positive for Companies like PolyMedix ($PYMX)
News from the FDA which declared its oprganizational support for a new pathway for review and approval of drugs to treat infections that are not susceptible to existing drugs said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. The new pathway was proposed by the Infectious Diseases Society of America in a statement submitted to the House Energy and Commerce Committee's health subcommittee. Under the proposal, products designated as "Special Population Limited Medical Use Drugs" could be studied in abbreviated clinical trials for specific populations, such as patients with drug-resistant infections, and measures would be taken to limit off-label use.
Speaking at a health subcommittee hearing Thursday, Woodcock also endorsed the goals of the Faster Access to Specialized Treatments (FAST) Act, which seeks to expand FDA's use of accelerated approvals. She said legislation instructing FDA to establish a new pathway for reviewing breakthrough drugs would be "helpful".
Daily Dose Conclusion: This news is positive for names like Polymedix (PYMX).
PYMX, fda | Print Article Email Article Posted on Friday, March 9, 2012 at 12:11PM Permalink in Specialty Pharma
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