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TXT FDA Asked to Stay Roxybond NDA Approval [2730 Words] [ Price : $8.95]
Pharmaceutical Manufacturing Research Services asks FDA to stay its approval of an Inspirion NDA for Roxybond.
05/18/2017
 
 
TXT Court Dismisses Eliquis Case [2780 Words] [ Price : $8.95]
Attorney James Beck says a New York federal court dismissed a suit against Bristol-Myers Squibb for not adding bleeding risk warnings to its Eliquis labeling because the changes sought are preempted by federal law.
05/18/2017
 
 
TXT Oncology ‘Excellence’ Center Handling Reviews: Pazdur [2758 Words] [ Price : $8.95]
FDA Oncology Center of Excellence director Richard Pazdur outlines the Center’s accomplishments since its 1/2017 founding.
05/18/2017
 
 
TXT Spark Rolling BLA for Retinal Disease [96 Words] [ Price : $8.95]
Spark Therapeutics completes a rolling BLA submission for voretigene neparvovec, an investigational, one-time gene therapy for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal disease.
05/18/2017
 
 
TXT FDA Clears Myoscience Pain Device for Knee Osteoarthritis [125 Words] [ Price : $8.95]
FDA clears a Myoscience 510(k) for its iovera device for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days.
05/18/2017
 
 
TXT FDA Extends Comment Period in Intended Use Rule [181 Words] [ Price : $8.95]
Federal Register notice: FDA extends the comment period until 7/18 on a final rule that clarifies for drug and device manufacturers the agency’s interpretation and application of its existing definitions of “intended use.”
05/18/2017
 
 
TXT AdvaMed Praises Bill Streamlining Some Device Approvals [2751 Words] [ Price : $8.95]
AdvaMed praises legislation to allow some low- and moderate-risk Class 2 medical devices to be cleared based on objective criteria without having to be substantially equivalent to a predicate device.
05/18/2017
 
 
TXT House Health Subcommittee Advances User Fee Bill [397 Words] [ Price : $8.95]
The House Energy and Commerce Subcommittee on Health advances the FDA Reauthorization Act that would reauthorize user fee programs for five years beginning 10/1.
05/18/2017
 
 
TXT CDER Holding Preventable Harm Symposium [2744 Words] [ Price : $8.95]
CDER’s John Whyte says a 6/15 symposium will look at ways to reduce preventable medication errors.
05/17/2017
 
 
TXT Price Wants FDA Reviews ‘100% User Fee Supported’ [2940 Words] [ Price : $8.95]
HHS secretary Tom Price calls on Congress to make all FDA medical product review activities 100% user fee supported.
05/17/2017
 
 
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