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Device Reporting Guidance Has Unwarranted Requirements: WLF

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Washington Legal Foundation says an FDA proposed guidance on medical device reporting imposes new requirements on manufacturers th...

FDA 510(k) Guidance Needs Significant Changes: Consultant

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Speakers at a Washington Legal Foundation briefing outline significant problems they see with FDAs draft guidance on the 510(k) pa...

Guidant Agrees to Pay $30 Million on Defective Devices

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Boston Scientific and its Guidant subsidiary agree to pay $30 million to settle government allegations that Guidant knowingly sold...

FDA Extends Feraheme sNDA Review by 3 Months

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FDA extends by three months its review of an AMAG Pharmaceuticals supplemental NDA for Feraheme (ferumoxytol) injection for intrav...

FDA Approves EMD Seronos Gonal-f RFF Redi-ject

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Merck subsidiary EMD Serono gains FDA approval for its Gonal-f RFF Redi-ject (follitropin alfa injection), a disposable pre-filled...

Advisors Asked About Impavido Safety, Effectiveness

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FDA asks Infective Drugs Advisory Committee members to discuss whether Paladin Therapeutics has demonstrated safety and effectiven...

FDA Cautions About St. Jude Amplatzer Adverse Events

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FDA says the St. Jude Amplatzer atrial septal occluder may have rare adverse events that could lead to emergency surgery.

FDA Panel to Review Vandas Tasimelteon NDA

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FDA tells Vanda Pharmaceuticals that the agencys Peripheral and Central Nervous System Drugs Advisory Committee 11/14 will review ...

CDER Promotion in Medication Error Prevention Office

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CDER promotes Division of Medication Error Prevention and Analysis deputy director Kellie Taylor to Office of Medication Error Pre...

Lowey Says Shutdown Hurting Vaccine Manufacturer

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Rep. Nita Lowey says the government shutdown has been preventing Protein Sciences from obtaining FDA approval for its Flublok vacc...