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Potential Foreign Object Recall Lake Champlain Chocolates Issues Voluntary Recall on Selected Milk Chocolate ProductsRECALLS

Lake Champlain Chocolates (LCC) is issuing a public alert and a voluntary recall on select LCC milk chocolate products from a determined best-by date range for potential foreign objects. LCC is issuing this recall after a consumer reported finding brittle plastic pieces in a fini...

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas DRUGS

On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-bas...

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Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health InfrastructureDRUGS

FDA and industry have to accelerate the adoption of advanced manufacturing technologies to strengthen the nation’s public health infrastructure. ...

Questions about TissuesBIOLOGICS

Information about tissues, questions and answers, donor screening and testing, donor eligibility...

What You Should Know - Reproductive Tissue DonationBIOLOGICS

Information that you may want to know before becoming a recipient of donated sperm....

Mytilini Enterprises LLC dba Bedford Pharmacy Inc. - 486159 - 01/11/2021DRUGS

Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated...

Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency DRUGS

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. ...

Influenza Virus Vaccine, H5N1 (for National Stockpile)BIOLOGICS

For active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine....

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