FDA Law Blog
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.
FDA Law Blog
SEPTEMBER 20, 2021
When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.
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FDA Law Blog
NOVEMBER 16, 2021
1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)
FDA Law Blog
OCTOBER 6, 2023
The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.
FDA Law Blog
NOVEMBER 22, 2023
The Flavor and Extract Manufacturers Association responded by submitting a food additive petition to FDA, requesting approval to use BVO in beverages at a maximum use level of 15 ppm. Over the past decade, beverage manufacturers have already reformulated their products to replace BVO with these alternatives.
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. Complaint at 2.
FDA Law Blog
MARCH 5, 2024
First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.
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