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Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advis...[ Price : $8.95]
PhRMA gives FDA general and specific comments on a draft guidance on using data monitoring committees in clinical trials.[ Price : $8.95]
FDA approves a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplasti...[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra...[ Price : $8.95]
FDA posts its official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has bee...[ Price : $8.95]
FDA denies a Hyman, Phelps & McNamara petition seeking permission to submit an ANDA for generic Imodium with two different strengt...[ Price : $8.95]
CDRH releases reports on its commitment to medical device innovation and safety.[ Price : $8.95]
Boston Scientific recalls its embolic agent Obsidio Embolic after an investigation finds that its use with the aliquot technique f...