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Browse Pickett, Joseph 1-17 out of 17 article(s) Title Type Date Words Legislation marks significant boost to FDA post-market safety efforts. May 6, 2008 584 FDAAA of 2007 to require more trial information at clinicaltrials.gov. Mar 25, 2008 503 REMS frequency seen increasing under FDAAA 2007, former chief counsel says. Mar 25, 2008 494 ADE inspections drop from fiscal '06, but 150+ ADE inspections expected in fiscal '08: Krueger. Report Jan 29, 2008 548 Safety report quality depends upon clinical expertise, direct questioning, HCP education. Jan 29, 2008 675 FDA issues early communication about ongoing review of Vytorin. Report Jan 29, 2008 592 Congress may subpoena FDA on Ketek data. Brief article Jan 29, 2008 288 Antidepressant studies that cast doubt on effectiveness went unpublished. Report Jan 29, 2008 796 FDA requiring suicide studies in drug trials. Report Jan 29, 2008 779 FDA clarifies recent OTC initiatives. Jan 29, 2008 424 Panel gives Entereg mixed review. Brief article Jan 29, 2008 188 Novartis ordered to pull Prexige off shelves in the Philippines. Report Jan 29, 2008 247 Merck to try again for approval of OTC cholesterol drug. Brief article Jan 29, 2008 276 FDA action prompts BDSI to develop safety plan for patch. Report Jan 29, 2008 480 FDA IT infrastructure 'problematic at best, dangerous at worst,' agency subcommittee reports. Jan 15, 2008 1079 FDA to issue guidance on new OTC drug, supplement AE reporting law. Feb 12, 2007 645 CDRH not dividing pre-/post-market adverse reports; AEs and recalls increasing. Feb 12, 2007 926

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