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The best way for device manufacturers to receive the fastest possible coverage decisions from the Centers for Medicare & Medicaid Services (CMS) is to submit all relevant information on their products during the initial request for a Medicare national coverage determination (NCD), the agency stated in a new draft guidance.
A trio of final guidance documents focused on developing new ways to minimize the safety risks of prescription drugs and biologics are not expected to lengthen the product-approval process, a top FDA official said.
Sentrx has completed an FDA electronic submissions pilot and has begun sending individual case safety reports (ICSRs) from a leading pharmaceutical company to the agency through the Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway, the technology company announced April 4.
A trio of final guidance documents focused on developing new ways to minimize the safety risks of prescription drugs and biologics are not expected to lengthen the product-approval process, a top FDA official said.
The FDA has reworked its guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products to include specific timelines for application review milestones.
The most reliable method for demonstrating the efficacy of a cancer drug or biologic is to show a statistically significant improvement in a clinically meaningful endpoint in blinded, randomized, controlled trials, but there are single-arm study approaches that might be successful in certain settings, explains a new FDA draft guidance.
Boehringer Ingelheim Pharmaceuticals has been cited by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) for running a journal advertisement containing unsubstantiated superiority claims about its stroke drug Aggrenox.
Investigators, sponsors and institutional review boards (IRBs) looking to reduce the time it takes to conduct multicenter clinical research should consider implementing a centralized IRB review process, suggests a new FDA draft guidance that describes how to initiate the review strategy.
The FDA’s final guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products now includes specific timelines for application review milestones — a change that will be welcomed by drugmakers, many of which criticized the initial draft document for being too vague.
The FDA’s three final guidances on minimizing safety risks of prescription drugs and biologics aim to make the agency’s risk management decisionmaking process more transparent, according to a top FDA official who also assured drugmakers that the recommendations are not expected to lengthen the product-approval process.