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Human Drugs

FDA Announces Pilots on CMC Changes, Hybrid Inspections

FDA announces two new pilot programs that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which the agency is a member, is...

Human Drugs

Gilead Resubmits NDA for HIV Therapy

Gilead Sciences refiles an NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for treating HIV-1 infection in heavily treatm...

Biologics

Panel Recommends Omicron-based Covid Booster Vaccines

FDAs Vaccines and Related Biological Products Advisory Committee votes 19 to 2 to recommend that the SARS-CoV-2 strain composition of Covid-19 vaccine...

Medical Devices

Acutus Expands Left-Heart Access Devices

FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use with the TruSeal and...

Federal Register

Guide on Oligonucleotide Drug Development

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...

Medical Devices

Nasal Spray Film Cleared for Allergic Rhinitis

FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.

Federal Register

Info Collection on Pilot Survey for Health Projects

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

Human Drugs

OTC Drug Proposal to Offer New Class of Products

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

Federal Register

AbbVie Redeemed Priority Voucher for Rinvoq sNDA

Federal Register notice: FDA announces that AbbVie had redeemed a priority review voucher to gain its 3/16 approval of a supplemental NDA for Rinvoq (...

Human Drugs

Nuvation Bio Phase 1 Trial Hit with Clinical Hold

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