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Following on the heels of other recent guidances intended to help firms better monitor drug-safety issues, the FDA released a final guidance March 31 that describes a method for summarizing identified drug risks, particularly those found early in the postmarketing period.
The FDA has revamped its guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products to include specific timelines for application review milestones -- a change that should come as good news to drug manufacturers, many of which criticized the initial version of the document for being too vague.
Describing the current treatments for systemic lupus erythematosus (SLE) as inadequate, a new FDA document aims to help industry develop new treatments for the immune system disease.
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conduct multicenter clinical research should consider implementing a centralized IRB review process, suggests a new FDA draft guidance that describes how to initiate the review strategy.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 is encouraging drugmakers to voluntarily submit pharmacogenomic data as part of an initiative to speed the development of personalized therapies based on patients’ genetic profiles, according to a new final guidance.
The Centers for Medicare & Medicaid Services (CMS) issued a final decision late last week that would immediately expand coverage of carotid artery stenting for high-risk patients with symptomatic narrowing of the carotid artery of 70 percent or more.
The FDA should overhaul its advisory committee process to end “promiscuous use” of scientists who have financial ties to firms whose products are up for consideration, according to a group of health-advocacy organizations.
The FDA needs to provide for greater specificity in the cross-labeling of combination products and give its Office of Combination Products (OCP) a greater role in product reviews, according to a report issued earlier this month by a panel of regulatory professionals.
The best way for drug and 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products during the initial request for a Medicare national coverage determination (NCD), the agency states in a new draft guidance.
Pharmaceutical companies find that out of all the topics covered in the Q7A GMP Guidance for Active Pharmaceutical Ingredients (API), the areas that cause the most confusion are validation, the definition of "blending," reprocessing and the definition of "starting material," according to a survey of eight PhRMA member companies.