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Comments Sought on Adverse Event Reporting During Pandemic

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Federal Register notice: FDA seeks comments on an information collection extension on the Guidance for Industry on Postmarketing A...

4 Warning Letters Sent to Marijuana-derived Product Marketers

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FDA sends Warning Letters to four companies that marketed marijuana-derived products as cancer treatments.

Comments Sought on Drug Safety Reporting Extension

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Federal Register notice: FDA seeks comments on an information collection extension on Postmarketing Safety Reports for Human Drug ...

Guidance on Device Patient Data Sharing

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Federal Register notice: FDA makes available a guidance entitled Manufacturers Sharing Patient-Specific Information from Medical D...

Multiple Violations in Kim Chemicals Inspection

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FDA warns Indias Kim Chemicals about CGMP and other violations in its manufacturing of OTC products.

Safety Concern Continues with Abbotts Absorb Scaffold: FDA

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An FDA safety update says that interim study results from a pivotal clinical trial continue to show an increased rate of major adv...

CGMP Violations at Accelerated Analytical Labs

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FDA warns Accelerated Analytical Laboratories about CGMP violations at its drug manufacturing facility.

FDA Recognizes Drug Inspections by 8 European Countries

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FDA says it will recognize drug manufacturing inspections from eight European countries, avoiding duplication of inspections and r...

Accelerated Approval for AstraZenecas Calquence

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As a condition of approval, FDA is requiring that AstraZeneca conduct additional studies to verify and describe anticipated clinic...

FDA Encouraging Device Security Updates

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CDRH associate director Suzanne Schwartz says the agency works with medical device manufacturers to address cybersecurity issues.