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With FDA’s new regulation of laboratory developed tests (LDT) that becomes effective July 5, the agency has issued a final guidance intended to help small entities comply. Read More
Parameters for slowing or blocking an FDA drug or device inspection are now available to manufacturers and storage facilities, following the agency’s release of its final guidance on the subject Friday. Read More
The agencies explain that “‘transparency’ describes the degree to which appropriate information about a MLMD is clearly communicated to relevant audiences.” Read More
The FTC submitted comment supporting the US Patent and Trademark Office (USPTO) April proposed rule that seeks a variety of changes to the Patent Trial and Appeal Board (PTAB) proceedings including when patent settlement agreements must be disclosed. Read More
In this issue of Quick Notes, we provide an eyebrow-raising peek at the European Medicines Agency’s newly announced 2025 marketing authorization fees as well as some insight on how the EU wants to ensure a steady supply of medical radioisotopes and two new Q&A docs — one for biosimilars and one for medical devices that incorporate a medicinal product. Read More