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FDA-RELATED NEWS
 
 
 
TXT Drug Recalls Down, Units Up
08/13/2019
 
 
TXT 3 Drug Companies Obstructed Investigation: Cummings
08/14/2019
 
 
TXT FDA, Syapse Doing RWE Regulatory Research
08/14/2019
 
 
TXT New Approach to Expedited Drugs Needed: New York Times
08/15/2019
 
 
TXT FDA/EMA Study Examines Drug Approval ‘Concordance’
08/16/2019
 
 
TXT FDA Resists Criticism of Postmarketing Requirements: Study
08/13/2019
 
 
TXT Osteoporosis Drug Evaluation Guidance
08/15/2019
 
 
TXT More FDA Clarity Needed on RWE Studies: Attorney
08/13/2019
 
 
TXT PhRMA Suggests Continuous Manufacturing Guidance Changes
08/14/2019
 
 
TXT Dem Senators Want AveXis Punished Over Data Manipulation
08/12/2019
 
 
TXT FDA Rejects 2 Dr. Reddy’s Generic Drug Applications
08/14/2019
 
 
TXT Since Our Last Issue ...
08/18/2019
 
 
TXT Product Approval Summaries
08/18/2019
 
 
TXT Latest Federal Register Notices
08/18/2019
 
 
TXT AbbVie’s Humira Follow-on Approved for Arthritis
08/16/2019
 
 
TXT Heart Valves Get Expanded Indication
08/16/2019
 
 
TXT Comments Sought on Benefit/Risk Communications
08/15/2019
 
 
TXT Pfizer Recalls 2 Relpax Lots
08/15/2019
 
 
TXT FDA Updating Inactive Ingredient Database
08/15/2019
 
 
TXT FDA Adds Answers to Laboratory Controls Guidance
08/14/2019
 
 
TXT Post Questions FDA Role in AI/ML Oversight
08/14/2019
 
 
TXT Revised Guide Gastroparesis Drug Development
08/13/2019
 
 
TXT Latest FDA Warning Letters
08/13/2019
 
 
TXT FDA Inactivating Some Drug Listing Records
08/13/2019
 
 
TXT QS Violations in Talon Inspection
08/13/2019
 
 
TXT CGMP Violation in Emcure Inspection
08/13/2019
 
 
TXT No Higher Prostate Cancer Risk with Entacapone
08/13/2019
 
 
 
 
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