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.
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Therapy Access
Articles currently tagged Therapy Access.
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.
FDA Flags Dough-To-Go for Food Safety Control Failures
A recent FDA action against Dough-To-Go, Inc. spotlights gaps in preventive food safety controls and what they mean for regulators and consumers.
How ICH Q10 Is Reframing the Pharmaceutical Quality System
A closer look at the ICH Q10 Pharmaceutical Quality System guideline and how regulators say it can help drug makers manage risk and consistency.
FDA’s ‘Information by Drug Class’ Effort: What It Is and What Comes Next
The FDA is organizing safety and availability information by drug class. Here is what that means for patients, prescribers and industry in the near term.
FDA Flags CGMP Failures at Alchymars ICM SM Over API Quality
U.S. regulators cite Alchymars ICM SM Private Limited for CGMP violations tied to active pharmaceutical ingredient quality and potential adulteration.
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