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Many FDA Digital Actions Coming

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Attorney Suzan Onel says FDA has an ambitious series of steps it plans to take through the first quarter of 2018 as part of its ne...

Child-Resistant Packaging Label Guidance

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FDA issues a draft guidance to help firms that want to include child-resistant packaging information in Rx or non-prescription dru...

Comments Sought on De Novo Device Submissions

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Federal Register notice: FDA seeks comments on a new information collection for De Novo Classification Process (Evaluation of Auto...

Antibacterial Therapies Guidance

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FDA publishes a guidance to help sponsors in clinical development of new antibacterial drugs.

Priority ANDA Guidance Seeks Excessive Info: Teva

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Teva asks FDA to revise a draft guidance on pre-submission facility correspondence associated with priority ANDA submissions to re...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Absonutrix and Medical Center Pharmacy.

FDA Clears Xavant Techs Waveform Neuromodulator

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FDA clears a Xavant Technology 510(k) for the Stimpod NMS460, a hybrid-pulsed radio frequency waveform neuromodulation device for ...

Sen. Blumenthal Bill on Device Cybersecurity

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Sen. Richard Blumenthal (D-CT) introduces a bill (S 1656) to amend the federal Food, Drug, and Cosmetic Act to provide cybersecuri...

Praise for BsUFA Statement of Work

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Four stakeholder groups praise FDA efforts in publishing the Biosimilar User Fee Agreement Statement of Work before the 10/1 antic...

Halt Unethical MINT Trial Enrollment: Public Citizen

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Public Citizen says the MINT trial violates ethical principles and should be suspended until more work is done on its protocol.