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FDA Issues Staff Social Media Policy

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FDA issues a policy on staff use of social media on behalf of the agency and its mission.

FDA Sends Info on Tropical Disease Vouchers to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget pertaining to a g...

Comments Sought on Safety Reporting, Electronic Submissions

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Federal Register Notice: FDA seeks comments on a proposed collection of information on the FDA Electronic Submission Gateway and t...

New Claims for Meridian BioSciences illumigene Pertussis Test

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FDA clears a Meridian Bioscience 510(k) for new claims for its illumigene pertussis molecular amplification test.

Guidance on Biosimilar Sponsor Formal Meetings

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Federal Register Notice: FDA releases a guidance: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Ap...

Regen BioPharma Gives FDA More Data on HemaXellerate

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Regen BioPharma submits data and responses to questions posed by FDA regarding its IND for HemaXellerate, a cellular drug designed...

FDA Clears Hikma Plant Corrective Actions

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FDA says Hikma Pharmaceuticals has sufficiently corrected GMP violations at its Portuguese drug manufacturing facility.

Feds Coordinate Dietary Supplement Enforcement

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Several federal agencies announce coordinated enforcement efforts against a number of dietary supplement manufacturers.

Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites Heritage Pharmaceuticals and Life Support Development.

Positive Results in Gilead Zydelig Study

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Gilead says its Phase 3 study of Zydelig combined with bendamustine and rituximab for treating patients with relapsed chronic lymp...