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FDA Approves EMD Seronos Gonal-f RFF Redi-ject

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

High Court Seeks Guidance on Post-market Device Problem Reports

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Attorney Jill Owens says the Supreme Court may be considering hearing an appeal of a 9th Circuit decision in a Medtronic infusion ...

Court Upholds Suit Based on Company Interactions with Doc

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An Indiana appeals court rules that a state law case involving common law negligence against Medtronic can go to trial.

Drug Makers Should Re-assess Contract Testing Agreements: Attorney

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Fox Rothschild partner David Restaino recommends that drug makers reevaluate their contracts with testing laboratories and assess ...

Hepatitis C Drug Development Guidance Out

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FDA publishes a guidance on hepatitis C antiviral drug development.