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Guide on Bladder Cancer Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant...

Guide on Renal Cell Carcinoma Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Ad...

FDA Complete Response Letter for Spero NDA

[ Price : $8.95]

An FDA complete response letter says a Spero Therapeutics NDA for tebipenem HBr tablets to treat adults with complicated urinary t...

Multiple Violations at Re-Gen Active Lab

[ Price : $8.95]

FDA warns Irving, TX-based Re-Gen Active Lab about multiple violations in its production and marketing of several cellular-based d...

API Deviations Seen in Fagron Group Inspection

[ Price : $8.95]

FDA warns St. Paul, MN-based Fagron Group about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Info Collection on Pilot Survey for Health Projects

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Federal Register notice: FDA sends to OMB an information collection entitled Pilot Survey to Develop Standardized Reporting Forms ...

OTC Drug Proposal to Offer New Class of Products

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FDA proposes to expand options for drug companies seeking to market a nonprescription drug product to allow an additional conditio...

AbbVie Redeemed Priority Voucher for Rinvoq sNDA

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Federal Register notice: FDA announces that AbbVie had redeemed a priority review voucher to gain its 3/16 approval of a supplemen...

Nuvation Bio Phase 1 Trial Hit with Clinical Hold

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FDA places a partial clinical hold on a Nuvation Bio Phase 1 dose escalation study of NUV-422 in solid tumors after receiving repo...

Vaccines Panel Mulls Omicron Boosters

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FDAs Vaccines and Related Biological Products Advisory Committee meets to discuss whether and how the SARS-CoV-2 strain compositio...