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TXT FDA Accepts Bristol-Myers sBLA for Opdivo [131 Words] [ Price : $8.95]
FDA accepts a Bristol-Myers Squibb supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma after prior sorafenib therapy.
05/24/2017
 
 
TXT Comments Sought on Strategic Stockpile Labeling Exceptions [130 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension on “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile — OMB Control Number 0910–0614.”
05/24/2017
 
 
TXT CBER Sends Letter to Firm Over Unapproved HIV Tests [124 Words] [ Price : $8.95]
CBER Office of Compliance and Biologics Quality cites the unnamed owner of a Web site (http://www.americanpumpkins.com) for promoting its In Home Blood Test for HIV 1 and 2 and the Oral In Home Saliva Test for HIV 1 and 2.
05/24/2017
 
 
TXT FDA Alert on Zoetis’ Noise Aversion Drug for Dogs [211 Words] [ Price : $8.95]
FDA issues an alert for veterinarians and dog owners about a risk of accidental overdose when in administering Zoetis’ Sileo (dexmedetomidin), an oral prescription gel for treating canine noise aversion.
05/23/2017
 
 
TXT Competition Promotes Lower Drug Prices: White Paper [2993 Words] [ Price : $8.95]
A Foundation for Research on Equal Opportunity white paper outlines ways to increase competition in the pharmaceutical sector to lower drug prices.
05/23/2017
 
 
TXT Gottlieb’s ‘Highest Initial Priority’ is Opioid Crisis [3004 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb says his highest initial priority is to identify additional steps the agency can take to help confront the country’s opioid epidemic.
05/23/2017
 
 
TXT Trump Budget Relies on User Fee Hike to Add $1.3 Billion [604 Words] [ Price : $8.95]
The Trump Administration releases its FY 2018 budget request that proposes to increase user fee collections by $1.306 billion (68%) over current FY 2017 levels to $3.223 billion.
05/23/2017
 
 
TXT Repro-Med Systems ’483 Released [2710 Words] [ Price : $8.95]
FDA releases an FDA-483 with eight inspection observations from Repro-Med Systems, Inc.
05/23/2017
 
 
TXT API Deviations Found in Changzhou Jintan Inspection [2790 Words] [ Price : $8.95]
FDA warns China’s Changzhou Jintan Qianyao Pharmaceutical Raw Materials Factory about deviations from CGMP requirements for active pharmaceutical ingredients.
05/23/2017
 
 
TXT Supreme Court Won’t Hear Park Doctrine Appeal [2768 Words] [ Price : $8.95]
Attorney Jennifer Thomas says the Supreme Court has declined to hear an appeal of a Park doctrine conviction by the DeCoster brothers.
05/23/2017
 
 
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