Returning Players: Original Applications That Are Back Before FDA After A “Complete Response” Letter
Novel products that could see approval in 2012 after addressing previous action letters.
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The court included its decision on Amarin’s ’s petition for a writ of certiorari among the single-line denials of nearly 200 appeals to consider decisions in civil litigation and convictions in criminal cases. However, Amarin still eyes curbing competition from omega-3 supplements.
Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.
FDA warns OHM Pharma for promoting topical formula containing homeopathic ingredients as teething product for infants. The firm also warned about drug and supplements GMP violations and was an easy target for FDA following release of draft guidance outlining its enforcement priorities.