FDA Law Blog: Biosimilars
MARCH 18, 2025
Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. The plain text of 35 U.S.C.
DrugBank
JUNE 18, 2025
Drug development is a complex and highly regulated process. While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations. Regulatory agencies, such as the U.S.
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Elrig
MARCH 25, 2025
After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona). There, he worked with the GENCODE consortium to establish foundational lncRNA gene annotations, which are considered a standard reference in the field.
FDA Law Blog: Drug Discovery
JANUARY 12, 2025
Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).
biobide
AUGUST 18, 2023
With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.
PPD
FEBRUARY 19, 2024
The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.
FDA Law Blog: Biosimilars
JUNE 13, 2024
Citing to a 2004 Supreme Court case, Verizon Commc’ns., 398 (2004), Teva argued that Amneal has no cause of action under antitrust law because the Hatch-Waxman Amendments impose a new statutory duty on a company to cooperate with competitors and established a remedy for breach of that obligation. of Trinko, LLP , 540 U.S.
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