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…As FDA acknowledged, this guidance does not address all suspect and illegitimate product-related issues, but it is a start. Interested parties should submit comments on the Draft Guidance within 60…
…members of the supply chain to collaborate on the potential challenges of exchanging Transaction Information/Transaction History/Transaction Statement (“TI/TH/TS” or “the three Ts”). Supply chain members must start passing TI/TH/TS on…
…will undoubetedly bring into play the complex patent resolution provisions added to the PHS Act by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The BPCIA created a…
…the comments be made in the primary version to the file. If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are…