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Reporting Requirements Abbreviated New Drug Application (ANDA)

Dechert LLP

Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

Dechert LLP on

In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more

Goodwin

Field Alert Reporting: Supplier Contracting Implications for Drug Developers

Goodwin on

For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for...more

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