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Gottlieb Outlines New Diagnostics Regulatory Framework

[ Price : $8.95]

FDA commissioner Scott Gottlieb outlines a new regulatory framework he has suggested to Congress for diagnostic tests.

Yuki Gosei Kogyo Inspection Observations

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FDA releases the FDA-483 with nine observations from an inspection at Japans Yuki Gosei Kogyo API manufacturer.

2 Voluntary Consensus Standards Guidances

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FDA publishes a draft guidance and a finalized guidance on voluntary consensus standards for medical devices.

5 Observations from Cook Pharmica Inspection

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FDA issues an FDA-483 with five inspection observations at Cook Pharmica.

Unichem Laboratories FDA-483

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FDA releases an FDA-483 issued following an inspection at Indias Unichem Laboratories drug manufacturing firm.

54 Product-Specific Drug Guidances Out

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FDA releases 54 product-specific drug guidances to promote generic competition.

Attorneys Analyze Medical Device Guidance Flood

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Two Kleinfeld, Kaplan and Becker attorneys analyze major medical device guidance documents issued in the first eight months of 201...

FDA Proposes Cutting Device Submission Copies

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FDA proposes to amend its rules to require a single electronic format submission for medical device premarket filings, rather than...

FDA Making FOIA Changes in Info Regs

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FDA says it wants to change its public information regulations to incorporate Freedom of Information Act changes and make the proc...

Pediatric Medical Device Development Grants

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FDA awards another round of pediatric device consortia grants to provide expert support to innovators of medical devices specifica...