2027 Drafting Manufacturing 
JURIST
APRIL 27, 2023
The EU Wednesday released a draft of its proposed overhaul of drug manufacturing laws. The changes have caused controversy among manufacturers, with some stating they will leave the region if the laws take effect. However, the changes sparked some pushback from the drug manufacturing industry.
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. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.
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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.
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)
Broadcast Law Blog
MAY 14, 2023
On a rolling basis through April 1, 2027, stations licensed in all other states will be subject to the Mid-Term Review on the fourth anniversary of the filing deadline for their most recent license renewal application.
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.
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