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2003

Manufacturing

Medical

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue. 5429, the “ Medication Affordability and Patent Integrity Act.”

Manufacturing

Manufacturing Provider IT Healthcare

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. See 21 C.F.R. 251.5; § 251.6(c).

Supply Chain

Supply Chain Manufacturing Chronic Condition Government

Primary Care Digest

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

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