The US Food and Drug Administration (FDA) recently published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device combination products are...more
Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well...more
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and...more
FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody...more
Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said the...more
Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more
6/11/2015
/ Best Management Practices ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Product Defects ,
Product Labels ,
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Technology