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FDA-RELATED NEWS
 
 
 
TXT CGMP Problems Found at 3 Mylan India Sites [427 Words]
08/18/2015
 
 
TXT FDA Looking for Device Reporting Pilot Participants [264 Words]
08/18/2015
 
 
TXT Court Cases on Preemption Updated [292 Words]
08/18/2015
 
 
TXT FDA Should End Industry Devices Influence: Public Citizen [281 Words]
08/17/2015
 
 
TXT Be Sure ‘Truthful and Non-misleading’ Speech Really Is [382 Words]
08/20/2015
 
 
TXT FTC Asks FDA to Reconsider Homeopathic Product Regs [212 Words]
08/21/2015
 
 
TXT FDA Approves Sprout’s Female ‘Sexual Desire’ Drug [495 Words]
08/18/2015
 
 
TXT PhRMA Urges FDA Halt to CMC Reporting Guidance [439 Words]
08/21/2015
 
 
TXT Amgen Pays $71 Million to States Over Off-label Promotion [564 Words]
08/18/2015
 
 
TXT Warning Letters Sent to Duodenoscope Makers [260 Words]
08/17/2015
 
 
TXT Product Approval Summaries [1071 Words]
08/23/2015
 
 
TXT Since Our Last Issue ... [598 Words]
08/23/2015
 
 
TXT Latest Federal Register Notices [2414 Words]
08/23/2015
 
 
TXT FDA Approving Almost All Drugs: Forbes [623 Words]
08/20/2015
 
 
TXT Multiple Violations in Walgreens Infusion Inspection [293 Words]
08/20/2015
 
 
TXT Ad Risk Communication Guidance Falls Short: Professor [924 Words]
08/20/2015
 
 
TXT Unilife Whistleblower Dismisses Lawsuit, Apologizes [338 Words]
08/20/2015
 
 
TXT United Therapeutics Sells Priority Review Voucher for $350 Million [82 Words]
08/19/2015
 
 
TXT GDUFA Industry Communication MAPP [237 Words]
08/19/2015
 
 
TXT General Support for Device PPI Guidance [517 Words]
08/19/2015
 
 
TXT CDRH in International Contents Table Pilot [246 Words]
08/18/2015
 
 
TXT Sen. Manchin Calls for Probe on Oxycontin Pediatric Approval [456 Words]
08/18/2015
 
 
TXT 3 Boxed Warnings in New Safety Labeling Changes [551 Words]
08/18/2015
 
 
TXT Cymbalta Case Curbs ‘Questionable’ Ex-FDA Expert [622 Words]
08/18/2015
 
 
TXT CBER Guidance on Vaccine Electronic Safety Reporting [119 Words]
08/18/2015
 
 
TXT QS Violations Seen in Transdermal Cap Inspection [403 Words]
08/18/2015
 
 
TXT Latest FDA Warning Letters [1001 Words]
08/18/2015
 
 
TXT CDER Wants More Patient-led Guidances Developed [345 Words]
08/18/2015
 
 
TXT Guidance on Engineering Tests for Stents [199 Words]
08/17/2015
 
 
TXT Court Approves Consent Decree Against Iowa Drug Firm [203 Words]
08/17/2015
 
 
 
 
The most authoritative FDA news analysis each week is found in the pages of Dickinson's FDA Review. Since 1984, this newsletter has been providing in-depth reports on the most significant FDA developments affecting the pharmaceutical, medical device, biologics and veterinary medicines industries. Unlike other media, FDA Review eliminates time-wasting minutia and presents in clear, concise language the essence of what's really important - and why. It is the publication that FDA officials themselves read. Delivered in the middle of each week, FDA Review presents:
  • The latest agency policy developments, often before they're officially announced;
  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving
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