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Attorney Anne Walsh outlines Justice Department changes to the Yates memo on individual accountability in criminal and civil cases...[ Price : $8.95]
The Federal Trade Commission says it shares FDA concerns about abuse of the citizen petition process to delay approval of generic ...[ Price : $8.95]
FDA releases an FDA-483 with six observations from an inspection at Spains Gadea Biopharma.[ Price : $8.95]
Federal Register notice: FDA has submitted to OMB an information collection extension entitled Guidance for Industry: Drug Supply ...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for InSightecs medical device E...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic Submission of Medical Devic...[ Price : $8.95]
FDA approves Olympus Spiration Valve System for treating severe emphysema, a progressive form of chronic obstructive pulmonary dis...[ Price : $8.95]
PHRMA praises FDA for its new draft guidance on adaptive designs for clinical trials of drugs and biologics.