Pharmaceutical industry news
Fresh coverage across pharma, biotech, medtech, research, approvals, and market-moving developments.
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Withdrawal of the Announcement of the Intent To Award a Single-Source Cooperative Agreement to Burke Law Group, PLLC in Houston, Texas
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), is withdra...
Notice of Award of a Sole Source Cooperative Agreement To Fund Public Health Center of the Ministry of Health of Ukraine
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Hu...
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or...
Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source...
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in...
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment...
Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public commen...
Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guid...
Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Hu...
Proposed Collection; 60-Day Comment Request; Data Use Certification for the NIH National Institute on Drug Abuse Data Share Site
The purpose of this notice is to inform the public of the information collection requirement for the...






