What the FDA’s Nerve-Drug Advisory Committee Is Chartered to Do
A closer look at the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee and how its charter shapes drug safety and effectiveness reviews.
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Therapy Access
Articles currently tagged Therapy Access.
What FDA’s Drugs@FDA Data Files Change — And What They Don’t
The FDA’s Drugs@FDA Data Files package makes approval data more accessible. Here’s what is actually available now, and how much it is likely to matter.
FDA Warns of Counterfeit Eye Drops Found in Florida and Georgia Stores
Federal regulators have identified counterfeit over-the-counter eye drops in retail stores in Florida and Georgia, prompting a safety warning to consumers.
FDA clarifies how biosimilar makers can change manufacturing postapproval
A new FDA Q&A aims to spell out what happens when biosimilar manufacturers change how products are made after approval—and what evidence regulators expect.
FDA Highlights New Drug Approvals for Rare Diseases
Recent FDA communications detail new drug approvals for rare diseases, outlining options for patients with limited existing treatments.
FDA Uses PREA Non‑Compliance Letters to Press Drugmakers on Pediatric Data
Regulators are formally warning drug sponsors that miss pediatric study deadlines under federal law, a move that can affect how medicines are labeled for children.
FDA Creates Quantitative Medicine Hub Inside Key Drug Review Center
The FDA’s drug center has launched a Quantitative Medicine Center of Excellence to coordinate how data-driven methods shape drug development and review.
FDA’s CDER Details Streamlined Nonclinical Studies and New Test Methods
FDA’s drug center is outlining when streamlined nonclinical studies and new testing methods are acceptable, with patient safety kept at the center.
FDA’s Chief Medical Office Publishes Three-Year Guidance Agenda
The FDA’s Office of the Chief Medical Officer has released a public agenda of guidance documents planned through 2027, inviting review and input.
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.
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.
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