FDA Law Blog
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.”
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. That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”.
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FDA Law Blog
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.
FDA Law Blog
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.
FDA Law Blog
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.
FDA Law Blog
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.
FDA Law Blog
AUGUST 29, 2024
After all, as we have written before in other contexts ( i.e. , the BLOCKING Act), “[I]f you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. But like cockroaches, some pieces of legislation are resilient and never seem to die.
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