ANDA PATENT CERTIFICATIONS SHOULD REFLECT GATT EXTENSIONS, PhRMA TELLS FDA; GPIA REQUESTS POLICY THAT PENDING APPLICATIONS ARE APPROVABLE ON OLD DATE
ANDAs must not be exempt from patent certification filings with respect to new patent expiration dates established by implementing legislation for the General Agreement on Tariffs & Trade, the Pharmaceutical Research & Manufacturers of America asserted in a Jan. 31 letter to FDA Commissioner Kessler.
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