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Mass Tort Implications of FDA’s First of its Kind State Drug Importation Program

For the first time, FDA approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the U.S., the first program of its kind to allow a state’s importation of pharmaceuticals approved by a...more

FDA Requires “Patient-Decision Checklists” for Breast Implants: What Could This Mean for Industry?

After two years of consideration, the FDA has restricted the sale of breast implants to healthcare providers that use an FDA-approved patient-decision checklist to discuss the benefits and risks of the implants with patients....more

FDA’s Proposal For Listing Materials on Medical Device Labeling: Considerations for Industry

Key takeaways - FDA is soliciting feedback on a proposed framework to change medical device labeling to require long-term devices to identify all constituent materials that might come into contact with human tissue and to...more

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