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The FDA provides clarity for drugmakers in a final guidance on how the agency’s considerations about a drug’s risks and benefits factor into NDA and BLA premarket and postmarket decisions. Read More
Though it might seem counterintuitive given the complex regulations and procedures required of the drug and device development industries, the real key to better quality lies in simplifying operations, said Greg Williams, industry veteran and a quality assurance consultant based in Dallas-Ft. Worth. Read More
A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process. Read More
CMS’s decision to allow coverage of positron emission tomography (PET) agents used to detect amyloid plaque deposits in the brain means patients suspected of having Alzheimer’s may now be covered for more than one PET scan per lifetime, and need not be in a clinical trial to receive the scan. Read More
The FDA’s new draft guidance provides recommendations on overall development programs for drugs to treat diabetic foot infections (DFI) as well as clinical trial designs. Read More
The FDA’s final guidance alerts drugmakers and compounders to the potential health hazard of alcohol (ethyl or ethanol) or isopropyl alcohol that is contaminated with methanol. Read More
Manufacturers of drugs and medical devices make several common errors when choosing the sample size for their sampling plan, but selecting too few samples routinely tops the list, according to Steven Walfish, president of Statistical Outsourcing Services. Read More
Over the past week, the FDA issued final guidances on assessment of tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance on quality considerations for topical ophthalmic drug products. Read More
Sponsors of postmarket trials and certain phase 3 trials can now expect the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to process their trial applications within two weeks rather than the statutory 30 days, as long as they meet certain criteria. Read More