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The FDA and AdvaMed recently hosted a public workshop aimed at improving the regulatory processes and oversight of medical devices once they reach the market.
Patient-reported outcome (PRO) data can provide evidence of a treatment benefit from the patient perspective, bolstering manufacturer’s claims about a drug’s benefit, according to FDA draft guidance.
Bristol-Myers Squibb (BMS) has notified healthcare professionals about revisions to the prescribing information on two of its oncology drugs: Hydrea (hydroxyurea) and Droxia (hydroxyurea).
The FDA on Jan. 18 issued a series of guidances to help drugmakers comply with its new final rule on labeling of human prescription drugs and biologic products.
The FDA Jan. 18 issued sweeping changes to its drug labeling rules and published four guidance documents designed to help drug manufacturers comply with the first major revision to labeling in more than 25 years.
The FDA’s new drug labeling rule already faces both a potential legal challenge from state officials and skepticism from stakeholders, various sources say.
The FDA has answered many important questions and clarified other issues in its new structured product labeling (SPL) implementation guidance and companion guides, experts tell DID.
Drugmakers that fail to lay good groundwork now for their structured product labeling (SPL) programs could leave “a lot of future benefits on the table,” according to an industry expert.
New River Pharmaceuticals has filed its new drug application (NDA) for NRP104, developed as an abuse-resistant follow-on drug to Shire Pharmaceuticals' attention-deficit/hyperactivity disorder (ADHD) drug Adderall XR.
Labeling changes proposed by the FDA to three lucrative asthma drugs are inconsistent with established treatment guidelines and could put patients at increased risk, according to GlaxoSmithKline (GSK), which manufactures two of the medicines.