FDA Law Blog
SEPTEMBER 16, 2024
Innovative manufacturing” is a somewhat ill-defined term, but the agency uses it to refer to any novel manufacturing that can increase product development speed, bolster supply chains, or prevent drug shortages. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.
PEMBlog
OCTOBER 31, 2024
However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. N Engl J Med 2018; 379:2015-2026. Parents often use probiotics, like Lactobacillus rhamnosus GG , hoping to reduce the severity of their child’s gastroenteritis.
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FDA Law Blog
MARCH 5, 2024
AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. Opinion at 17. see also 42 U.S.C. 1320f-1(e)(1)(A).
FDA Law Blog
NOVEMBER 22, 2022
Gaulkin — At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss. 20, 2026.
Physician's Weekly
JUNE 26, 2025
system for monitoring the rare ill effects of vaccines. The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. Kennedy Jr. forced him out in May. But for Dressen and others convinced the vaccines injured them, their experiences were symptomatic of a well-intentioned but flawed U.S. The current U.S.
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