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Workshop on Opioid Packaging/Storgage/Disposal

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Federal Register notice: FDA announces a 12/11-12 public workshop on Packaging, Storage, and Disposal Options To Enhance Opioid Sa...

FDA Denies PEG 3350 Selenium Petition

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FDA denies an Empire State Consumer Project petition asking that it test PEG 3350 products for selenium and recall any such produc...

FDA Denies PMRS Requested Stay of Roxybond Approval

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FDA denies a Pharmaceutical Manufacturing Research Services petition seeking a stay in the effective date of agency approval of In...

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.

Pfizer Addressing Hospira Problems to Remediate by Next Year

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Pfizer officials say they have submitted a corrective and preventative action plan to FDA on remediating GMP issues at Hospira leg...

Lancet Oncology Commission Priorities

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The Lancet Oncology Commission outlines future cancer research priorities for the U.S. Cancer Moonshot.

Advisors Back Indivior Opioid Use Disorder Drug

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Members of two FDA advisory committees vote to recommend approval of Indiviors RBP-6000 for treating adults with opioid use disord...

FDA Clears Luminex Aries Strep Assay

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FDA clears a Luminex 510(k) for the ARIES Group A Strep Assay for detecting Streptococcus pyogenes from throat swab specimens usin...

Comments on Device Software Change Guidance

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Stakeholders raise varying issues on an FDA draft guidance on submitting a 510(k) for medical device software changes.