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MAPP on Reviewing DEA Research Protocols

[ Price : $8.95]

FDA issues a MAPP on responsibilities and procedures for the CDER controlled substances staff to review and comment on DEA researc...

Scholars Question FDA Drug Importation Rule: Report

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A University of Pennsylvania Law School regulatory analysis examines a Council on Foreign Relations working paper critiquing the n...

ICAN Wants Tougher Covid Vaccine Efficacy Standards

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The Informed Consent Action Network asks FDA to order changes to the Phase 3 trial protocols for four Covid-19 vaccines that it sa...

Hahn Outlines Covid, Other Agency Successes

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FDA commissioner Stephen Hahn says the agency is meeting many of its FY 2020 goals in addition to all of its Covid-19 work.

Beyond Air Submits PMA for LungFit PH

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Beyond Air says it submitted a PMA application to FDA for its LungFit PH to treat persistent pulmonary hypertension of the newborn...

Comments on Therapeutic Protein Guidance

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Two stakeholders give FDA recommendations on a draft guidance on assessing drug-drug interactions in therapeutic proteins.

Info Collection for In Vivo Radiopharmaceuticals

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Federal Register notice: FDA seeks comments on an information collection extension for Regulations for In Vivo Radiopharmaceutical...

OMB Approves 7 FDA Information Collections

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Federal Register notice: FDA has published a list of seven information collections that have been approved by OMB.

Pfizer Says Positive Results in Abrocitinib Study

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Pfizer says its investigational atopic dermatitis drug abrocitinib met its primary and key secondary endpoints in the Phase 3 JADE...

Senate Spending Bill has $50 Million Boost for FDA

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A U.S. Senate Appropriations Committee-released bill for fiscal year 2021 proposes $3.21 billion in discretionary funding for FDA,...