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TXT Developing a New Drug Costs $2.6 Billion: Tufts [439 Words] [ Price : $8.95]
A Tufts Center for the Study of Drug Development analyses says the cost of developing an approved new drug has increased to $2.6 billion.
11/18/2014
 
 
TXT Wells Pharmacy Network Warned About Multiple Violations [476 Words] [ Price : $8.95]
FDA’s Florida District Office warns Wells Pharmacy Network about drug compounding and other violations.
11/18/2014
 
 
TXT QS Violations Found at MKL Diagnostics [297 Words] [ Price : $8.95]
FDA warns Sweden’s MKL Diagnostics about Quality System violations in its production of diagnostic tests.
11/18/2014
 
 
TXT FDA Clears AdvaDx mecA XpressFISH Assay [84 Words] [ Price : $8.95]
FDA clears an AdvanDx 510(k) for its new mecA XpressFISH assay for detecting methicillin-resistant and methicillin-susceptible Staphylococcus aureus in blood culture samples.
11/18/2014
 
 
TXT High-powered Lawyers Fighting LDT Proposal [322 Words] [ Price : $8.95]
The American Clinical Laboratory Association says former solicitor general Paul Clements and Harvard law professor Lawrence Tribe will represent it in its fight against FDA over laboratory-developed tests.
11/18/2014
 
 
TXT FDA Revises Guidance on 505(q) Citizen Petitions [227 Words] [ Price : $8.95]
FDA posts a revised guidance on “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q)of the Federal Food, Drug, and Cosmetic Act.”
11/18/2014
 
 
TXT OIG Lists FDA Drug Safety Tasks [262 Words] [ Price : $8.95]
The HHS Inspector General says there a number of tasks FDA needs to do to continue to ensure the safety of drugs and medical devices.
11/18/2014
 
 
TXT Guidance on Rare Pediatric Disease Vouchers [109 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Rare Pediatric Disease Priority Review Vouchers.
11/17/2014
 
 
TXT FDA Withdraws 14 NDAs [36 Words] [ Price : $8.95]
Federal Register Notice: FDA withdraws approval of 14 NDAs from multiple application holders due to a failure to file annual reports.
11/17/2014
 
 
TXT FDA Corrects Notice on Withdrawn Drug Products [170 Words] [ Price : $8.95]
Federal Register Proposed rule: FDA corrects the Regulatory Information Number in a 7/2 notice on additions and modifications to a list of withdrawn drugs for reasons of safety or effectiveness.
11/17/2014
 
 
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