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. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny.

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Manufacturing Provider IT Healthcare 105

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.

Manufacturing 40

Manufacturing IT Patients Provider 40

Tiny Physician

OCTOBER 17, 2021

One trial was conducted to find whether it is effective in fever on children post-DPT vaccination, another one on neonatal calf diarrhea (an animal study), and the last one on its effect on patients with Arsenic toxicity (4). Contrary to our beliefs, the second wave came and exposed all the weaknesses of our health system. Dipankar et.

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Vaccination Government Physicals IT 52

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). See 21 C.F.R.

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Supply Chain Manufacturing Chronic Condition Government 59