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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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