Texas Compounding Pharmacy Recalls Glutathione Injection Nationwide
Optimal Balance Pharmacy in Houston has issued a voluntary nationwide recall of a lot of compounded glutathione injectable vials, reaching down to patients.
Tag • 34 articles
Therapy Access
Articles currently tagged Therapy Access.
How the FDA’s Competitive Generic Therapy Pathway Shapes Drug Access
The FDA’s Competitive Generic Therapy approvals list offers a narrow but telling view into how regulators are trying to push more generics into markets with little or no competition.
FDA Sets Updated Intake Limits for Nitrosamine Drug Impurities
FDA’s drug center has updated its recommended limits for nitrosamine drug substance-related impurities, shaping how manufacturers manage cancer-linked risks.
How FDA Patent Certifications Shape the Path for Generic Drugs
FDA patent certifications and suitability petitions quietly determine when and how generics can reach patients. Here is what they do and why timing matters.
What FDA’s Generic Drug Facility Lists Signal — and What They Don’t Yet
The FDA’s Generic Drug Facilities, Sites and Organization Lists are live. Whether they become a formal, near-term reference point is less certain.
FDA Probes Rare Neurologic Complications Tied to Common Anesthetic
U.S. regulators are examining reports of catastrophic brain injury and death after sevoflurane anesthesia in patients with suspected genetic risk.
BsUFA IV and FY 2028: What We Actually Know Right Now
With thin public evidence and a long lead time, the odds of BsUFA IV’s FY 2028 plans being locked in next week look low—and hard to quantify.
FDA Posts Frequently Requested Foreign Drug Plant Inspection Records
FDA is proactively releasing inspection and compliance records for foreign drug manufacturers, aiming to speed access to information often sought through FOIA.
BsUFA IV and FY 2028: What Is Known—and What Is Not
With BsUFA IV now law, attention turns to how far its framework really extends toward FY 2028—and what that means for biosimilar oversight.
FDA Outlines Generic Drug User Fee Amendments Framework
FDA details how the Generic Drug User Fee Amendments work, including fee types and payment procedures for companies that make generic medicines.
How the FDA’s Competitive Generic Therapy Pathway Shapes Drug Access
The FDA’s Competitive Generic Therapy pathway targets drugs with little or no competition. Here’s how it works, who benefits, and what remains uncertain.
Why Individual Case Safety Reports Sit at the Heart of Drug Safety
A closer look at the FDA’s Individual Case Safety Reports and how this data standard shapes the way potential drug side effects are tracked.
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