News & Analysis as of

Regulatory Standards Premarket Approval Applications

Faegre Drinker Biddle & Reath LLP

Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA...more

Patterson Belknap Webb & Tyler LLP

2017 Biosimilar Approvals in Europe

The European biosimilar market has expanded at record pace in 2017.  The EMA approved marketing of sixteen biosimilar products referencing seven different innovator biologic products.  For five of the innovator products –...more

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