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FDA Adds Answers to Laboratory Controls Guidance

[ Price : $8.95]

FDA adds three questions and answers to the laboratory controls section of a guidance on current good manufacturing practices.

PhRMA Suggests Continuous Manufacturing Guidance Changes

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PhRMA makes general and detailed recommendations for changes to an FDA draft guidance on continuous manufacturing quality consider...

Info Collections Consolidated for Informed Consent/IRBs

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Federal Register notice: FDA seeks comments on an information collection revision for Protection of Human Subjects; Informed Conse...

FDA Approves Pretomanid for Treating Some TB

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FDA approves Pretomanid to be used in combination with two other drugs to treat a limited and specific population of adult patient...

FDA Rejects 2 Dr. Reddys Generic Drug Applications

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FDA issues Dr. Reddys Laboratories two complete response letters for generic copies of Tevas multiple sclerosis drug Copaxone (gla...

FDA to Inactivate Drugs Not Listed Properly

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Federal Register notice of intent: FDA announces its intention to begin inactivating drug listing records that are improperly list...

3 Drug Companies Obstructed Investigation: Cummings

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Rep. Cummings and Sen. Sanders ask three generic drug companies for pricing information and say the companies appear to have coord...

Pollogens RF Home-Use Skin Device Cleared

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FDA clears Pollogens radiofrequency home-use device TriPollar Stop for treating the face and the neck to eliminate aging signs and...

Mammography Quality Assurance Advisory Panel Renewal

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Federal Register notice: FDA renews the National Mammography Quality Assurance Advisory Committee for an additional two years.

Comments Sought on Device Q-Submission Program

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Federal Register notice: FDA seeks comments on an information collection extension for its Q-Submission Program for Medical Device...