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A landmark legal case over 3D-printed guns doesn’t involve FDA – but it is worth considering how the issues are likely to apply to the drug approval process in years to come. The right to bear arms may rely on the Second Amendment, but the key for FDA is how courts look at the First Amendment in the context of new technology.

FDA Regulation

3D-Printing Final Guidance Clarifies Manufacturing Practice Expectations

A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.

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US FDA Progress Report Highlights Biomarkers, Continuous Manufacturing, Antibiotic Testing

Agency documents its regulatory science accomplishments to advance product development and manufacturing and ensure the safety and effectiveness of marketed products.

BioPharmaceutical Regulation

Venture Funding Deals, August 2016

Derived from Strategic Transactions, Informa's premium source for tracking life sciences deal activity, the Venture Funding Deals column provides a comprehensive monthly review of emerging biopharmaceutical companies that have received venture funding. This month’s column covers deals announced June through July 2016.

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