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HHS Restores its Delegation of Authority to FDA

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HHS restores FDAs authority to issues regulations without HHS authority, which was removed late in the Trump Administration.

FDA Accepts sNDA for Adult ADHD Drug

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FDA accepts for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating...

MoleKule 510(k) Cleared for Air Purifier

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FDA clears a Molekule 510(k) for its existing air purifier, Air Pro, classifying it as a Class 2 medical device for medical use fo...

Mammography QA Panel Renewed for 2 Years

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Federal Register notice: FDA renews its National Mammography Quality Assurance Advisory Committee for an additional two years beyo...

Limited, Not Full-scale Booster Shots Mulled

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FDA cautions that it may only be able to give the green light for booster shots later this month to those vaccinated with the Pfiz...

Milestone Reached on Competitive Generic Therapies

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CDER Office of Generic Drugs reaches the milestone of approving more than 100 generic drug applications with a Competitive Generic...

Panel to Discuss Pfizer Booster Vaccine 9/17

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FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTechs supplemental ...

FDA Approves 6-Month Schizophrenia Drug

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FDA approves Janssens Invega Hafyera six-month atypical antipsychotic injection for some adult schizophrenia patients.

FDA Refusing to Approve ITCA 650

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FDA posts a Federal Register notice of its intent to not approve an Intarcia NDA for a diabetes drug/device combination product.

Info Collection on Device Establishment Fees

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Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FD...