2027 Regulations Treatment 
The Pharma Data
JANUARY 26, 2021
Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. billion by 2027. (OTCQB: QBIO), announced today that the U.S.
FDA Law Blog: Biosimilars
JULY 24, 2023
This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.
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The Premier Consulting Blog
NOVEMBER 20, 2023
The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Agency IQ
FEBRUARY 21, 2024
Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.
Agency IQ
AUGUST 2, 2024
What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.
The Pharma Data
JUNE 16, 2025
This significant move underscores BioMarin’s ongoing expansion and strengthening of its portfolio in enzyme therapy a key area for the treatment of rare and serious disorders with high unmet medical need. This is where INZ-701 comes in.
Agency IQ
JUNE 28, 2024
Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. In addition, the law prohibits the sale of carpets or fabric treatments containing PFAS as of January 1, 2023.
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