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First Psychedelic NDA Filing Claimed for PTSD Therapy

[ Price : $8.95]

MAPS Public Benefit Corp. files what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine ca...

New Genetic Metabolic Disease Treatment A/C

[ Price : $8.95]

FDA says it is creating a nine-member Genetic Metabolic Diseases Advisory Committee.

Strengthen Botox Safety Warning: Public Citizen

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Public Citizen calls on FDA to strengthen the Botox Boxed Warning to highlight the risk of systemic iatrogenic botulism and relate...

Advanced Manufacturing Technologies Guidance

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FDA publishes a draft guidance on the Advanced Manufacturing Technologies Designation Program and its benefits for drug developmen...

Dolor Tech Settles Over Migraine Device

[ Price : $8.95]

Utah-based medical device company Dolor Technologies settles False Claims Act charges with the federal government over a device it...

Peptide Clinical Pharmacology Guidance

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FDA publishes a draft guidance with clinical pharmacology considerations to assist industry in developing peptide drug products.

Risk-Based Approach to Therapeutic Protein DDI

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CDER Office of Clinical Pharmacology policy lead Qin Sun uses a podcast to explain the agencys risk-based approach to evaluating d...

CDISC Study Tabulation Model Version 3.4

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Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Con...

FDA May Not be Ready for LDT Rule: Attorney

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Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests wit...

Oncology Drug Dose Optimization Often Deferred: Analysis

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More than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement to obtain better dosing (o...