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Integra Resolves NJ Manufacturing Issues Cited by FDA

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FDA tells Integra LifeSciences that it has addressed GMP violations cited in a 2011 Warning Letter relating to its Plainsboro, NJ ...

Court Dismisses Medtronic Sprint Lead Case

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A Nevada federal court agrees with Medtronic and dismisses as preempted by federal law a suit against the company alleging injurie...

FDA Awards NIMS Data Submission Contract

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FDA awards a contract to PointCross Life Sciences for NIMS software development and life cycle management.

FDA Finds Deficiencies in Amag Feraheme sNDA

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FDA identifies deficiencies in an Amag Feraheme sNDA and delays a decision until 10/21.

FDA Grants 2 Orphan Drug Designations for Bayers Riociguat

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FDA approves two orphan drug designations for Bayers riociguat.

Shuren: Well Meet or Exceed New User Fee Goals

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CDRH director Jeff Shuren says the Center is currently on track to meet or exceed new user fee goals negotiated under the FDA Safe...

Comments Sought on Antimicrobial New Animal Drugs

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Federal Register Notice: FDA seeks comments on a proposal on data collected from sponsors of antimicrobial new animal drugs.

Committees Reach Drug Compounding Agreement

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Members of the House and Senate say they are agreed on a bill that will increase FDA oversight of drug compounding and improve dru...

In Immediate Effect Guidances Soon from CDRH: Atty.

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Attorney Allyson Mullen sees CDRH soon issuing Immediate In Effect guidance documents.

BabyBIG Lot 5 Dosage Decreased to Extend Supply

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FDA approves a dosing decrease and extended expiration date for Lot 5 of botulism immune globulin intravenous (human), known as Ba...