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FDA Posts Approved PMAs

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Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.

WLF Cries Foul on CDC Opioid Prescribing Guideline

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The Washington Legal Foundation calls on the Centers for Disease Control and Prevention (CDC) to withdraw its Draft Guideline for ...

FDA Accepts Sandoz Neulasta Biosimilar Application

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FDA accepts Sandoz regulatory submission for a biosimilar of Amgens Neulasta.

FDA Approves Medtronic MyCareLink Monitor

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FDA approves Medtronics MyCareLink remote pacemaker monitoring system.

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...