FDA Law

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.”

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FDA Law

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.

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FDA Law

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). N/A June 30 The manufacturer must accept the price or counteroffer—with a rationale. CMS may respond to the counteroffer.

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FDA Law

JUNE 15, 2022

The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Im­provement, and Modernization Act in 2003. Becerra, No.

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FDA Law

MAY 25, 2022

As a result, fewer generic drug manufacturers are likely to make the significant investment needed to challenge patent estates on expensive brand-name drugs, even when those challenges could have been successful or resulted in favorable settlements. 2853 , or “BLOCKING Act”), the “ Expanding Access to Low-Cost Generics Act of 2021 ” ( S.

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FDA Law

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately.

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FDA Law

AUGUST 29, 2024

Like previous iterations of the bill, it would amend the FTC Act to add new Section 27, which provides, in part, that: (A) In general.—Subject 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. But like cockroaches, some pieces of legislation are resilient and never seem to die.

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