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TXT Guidance on Medical Device Study Adaptive Designs [5229 Words] [ Price : $8.95]
FDA publishes a guidance on planning and implementing adaptive designs for medical device clinical studies.
07/26/2016
 
 
TXT Real-World Evidence Guidance Out [2766 Words] [ Price : $8.95]
FDA issues a guidance on uses of real-world data and evidence in medical device regulatory decisions.
07/26/2016
 
 
TXT CGMP Problems in Denmark’s ALK-Abello [2771 Words] [ Price : $8.95]
FDA sends an untitled letter to Demark’s ALK-Abello about CGMP violations in its manufacturing of licensed biological drug products and intermediates.
07/26/2016
 
 
TXT Democratic Platform Silent on FDA Reforms; Eyes Drug Costs [1597 Words] [ Price : $8.95]
The 2016 Democratic Party Platform skips FDA, unlike last week’s GOP Platform that highly criticized the agency and pledged reforms.
07/26/2016
 
 
TXT Grand Jury Indicts Freedom Pharma Owner, Employees [1258 Words] [ Price : $8.95]
A federal grand jury returns an indictment charging two Florida residents and one North Carolina resident with manufacturing and distributing performance enhancing drugs in violation of FDA regulations.
07/26/2016
 
 
TXT CDRH Reviews Early Feasibility Study Advantages [1786 Words] [ Price : $8.95]
CDRH says early feasibility studies conducted in the U.S. can give medical device developers important FDA feedback early in the development process, which may improve the development strategy and reduce the chances that unnecessary testing is completed.
07/26/2016
 
 
TXT Fluoroquinolone Antibiotic Warnings Updated [2815 Words] [ Price : $8.95]
FDA says it has updated risk warnings and limitations on use for approved fluoroquinolone antibiotics.
07/26/2016
 
 
TXT False Claims Act Penalties to Double Next Week [1483 Words] [ Price : $8.95]
Effective next week, the Department of Justice nearly doubles the per-claim penalties it imposes under the False Claims Act, penalties that are often imposed on the health care industry.
07/26/2016
 
 
TXT Sequencing Guidance Raises Questions: Attorney [2694 Words] [ Price : $8.95]
Attorney Gail Javitt raises questions she says arise out of an FDA draft guidance on next generation sequencing technology regulation.
07/26/2016
 
 
TXT House Democrats Want Theranos Answers [2800 Words] [ Price : $8.95]
Democratic leaders of the House Energy and Commerce Committee ask FDA and CMS for information on their work to bring Theranos into compliance.
07/26/2016
 
 
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