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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Concept Labs, Forest Labs, Drs. Foster and Smith, Hamilton Medical Center, Ovati...

Center Directors Support Critical Path

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FDA Center directors, participating in a roundtable discussion of the agencys Critical Path Initiative, provide anecdotal impressi...

CBER Advancing Electronic Labeling Submissions

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CBER senior program management officer Vada Perkins discusses mandatory electronic labeling submissions that become effective 10/1...

CGMP Violations at Concept Laboratories

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A Chicago District Office Warning Letter says cGMP violations were found at Concept Laboratories, which also is manufacturing and ...

FDA Approves Mylans Generic Risperdal

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FDA approves Mylans ANDA for a generic form of Janssens Risperdal.

Boxed Warnings for Antipsychotics

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FDA announces August labeling changes to 41 drugs, including boxed warnings for 12 antipsychotics.

CDER Good Review Practices to Engage Industry Earlier

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CDER deputy director Douglas Throckmorton tells a regulatory affairs meeting that new policies under the Centers Good Review Manag...

Risk Info Not in Panhematin Letters

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CBERs Office of Compliance and Biologics Quality says Ovation Pharmaceuticals healthcare provider letters on Panhematin dont give ...

FDA Places Import Alert on 2 Ranbaxy Plants

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FDA warns Ranbaxy Laboratories over cGMP problems at two facilities in India and issues an Import Alert for more than 30 generic d...

Info on Postmarketing Adverse Events to OMB

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Federal Register Notice: FDA sends to OMB a proposed collection of information on postmarketing adverse event reporting for nonpre...