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OMB Approves Seven Information Collections

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OMB approves seven information collections that include humanitarian-use devices, Right-to-Try Act reporting, and positron emissio...

Comments on Immune-Mediated Adverse Reaction Guidance

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Three drug companies comment on an FDA draft guidance on immune-mediated adverse reactions in cancer drug trials.

Info Collection on Fellowship/Trainee Programs

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Federal Register notice: FDA sends to OMB an information collection extension entitled Conflict-of-Interest Information for Partic...

Independent FDA Needed to Stop Political Meddling: GAO

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A new Government Accountability Office report offers recommendations to shield FDA and other HHS agencies from political interfere...

Drug Promotion Research on Mechanism of Action OKd

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Federal Register notice: FDA announces that OMB has approved a new information collection entitled Targeted Mechanism of Action Pr...

FDA Debars Kempema for 5 Years

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Federal Register notice: FDA issues an order debarring David J. Kempema for five years from importing or offering for import any d...

Harmonize Innovative Manufacturing Regulation: PhRMA

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Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufac...

AdvaMed Supports Breakthrough Device Guidance Updates

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AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.

VALID Could Hurt Home Sample Testing: Attorneys

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Two Hyman, Phelps attorneys say the VALID bill contains what appears to be an inadvertent provision that could adversely affect te...

Fresenius Kabi Gains Approval for Humira Biosimilar

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FDA approves a Fresenius Kabi BLA for Idacio (adalimumab-aacf), a biosimilar product referencing AbbVies Humira (adalimumab).