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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The FDA’s new draft guidance provides recommendations on overall development programs for drugs to treat diabetic foot infections (DFI) as well as clinical trial designs.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tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance on quality considerations for topical ophthalmic drug products.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
Companies manufacturing drug-device combination products must determine whether the benefits associated with each constituent part and the overall product outweigh the risks, says Susan Neadle, president of Combination Products Consulting Services. Read More
The FDA’s newest draft guidance discusses quality considerations for ophthalmic drugs, including ways to assess impurities, evaluate visible contaminants, design containers and conduct stability studies. Read More
The burden is on companies to convince health regulators that an effective quality management maturity (QMM) program is built into its governance structure, according to a pair of Merck executives who spoke at WCG Clinical’s virtual Good Manufacturing Practice (GMP) Quality vSummit Wednesday. Read More