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Comments filed on the FDA’s proposed guidance on potency assurance for cellular and gene therapy (CGT) products reflect the intricacies that set these treatments apart from drug interventions. Read More
AstraZeneca has sued to block an Arkansas law that requires the company to ship its drugs to any pharmacy — for-profit or otherwise — working with hospitals participating in the controversial 340B federal discount program. Read More
Six manufacturers of numbing gels, creams and sprays marketed to relieve pain from cosmetic procedures have received FDA Warning Letters for concentrations of lidocaine in their products in excess of the allowance of 4 percent for OTC topical pain relief products. Read More
Comments are sought by the Scientific Committee on Health, Environmental and Emerging Risks on an update of the European Commission guidelines on the presence of phthalates in medical devices. Read More