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TXT Report Examines FDA, Other Agencies’ Spending on Guns [1213 Words] [ Price : $8.95]
A new report by OpenTheBooks.com examines the purchases of military-style weapons by federal agencies, including FDA.
06/27/2016
 
 
TXT Hill Seeks Answers to Confidentiality After Insider Trading Scandal [325 Words] [ Price : $8.95]
House Energy and Commerce Committee chairman Fred Upton (R-MI) and Health Subcommittee chairman Joseph Pitts (R-PA) write FDA seeking answers about its procedures to product trade secret and confidential information in the wake of a recent insider trading scandal.
06/27/2016
 
 
TXT CDRH, Industry Mull Improvements to Pre-Submission Process [1451 Words] [ Price : $8.95]
CDRH and the medical device industry explore adding more resources and performance goals under the next Medical Device User Fee Program to improve the Center’s Pre-Submission process.
06/27/2016
 
 
TXT Report Recommends ‘Real World’ Evidence Programs for FDA [1502 Words] [ Price : $8.95]
The Bipartisan Policy Center issues a new report on “Using Real-World Evidence to Accelerate Safe and Effective Cures that offers recommendations for FDA to help advance medical innovation.
06/24/2016
 
 
TXT Bill Introduced to Reduce Biologic Exclusivity to 7 Years [1309 Words] [ Price : $8.95]
Rep. Jan Schakowsky (D-IL) and Sens. Sherrod Brown (D-OH) and John McCain (R-AZ) introduce the “Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act” that would reduce biologic exclusivity periods from 12 years to seven years.
06/24/2016
 
 
TXT Blindsided? FDA Ponders CDC’s ‘Ineffective’ Rating of FluMist [537 Words] [ Price : $8.95]
FDA plays catch-up on a sudden CDC finding that its 87% effectiveness finding for MedImmune’s FluMist 13 years ago is now worth only 3% and therefor useless for patients in the coming flu season.
06/24/2016
 
 
TXT FDA OKs Protein Sciences Extended Shelf Life for Flublok [145 Words] [ Price : $8.95]
FDA approves a Protein Sciences BLA supplement to extend the shelf life for Flublok, its seasonal influenza vaccine.
06/24/2016
 
 
TXT CDER Technical Guide on Quality Metrics [1576 Words] [ Price : $8.95]
CDER releases a “Quality Metrics Technical Conformance Guide” that is intended to serve as the technical for implementing its earlier draft FDA guidance on Request for Quality Metrics.
06/24/2016
 
 
TXT Medifirst Solitions Responds to 510(k) Request for Information [1195 Words] [ Price : $8.95]
Medifirst Solutions files a 510(k) for its Time Machine TTML-8102000 Laser Thermal Therapeutic Device, and it has responded to a CDRH request for more information.
06/24/2016
 
 
TXT Pharmacist Group Reverses Policy to Urge DTC Ban [1448 Words] [ Price : $8.95]
The American Society of Health-System Pharmacists approves a policy that urges Congress to ban all direct-to-consumer advertising of prescription drugs and medication-containing devices.
06/24/2016
 
 
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