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FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products By Mark Durivage, Quality Systems Compliance LLC On June 21, 2021, the FDA released a new guidance, Chemistry, Manufacturing, and Controls Changes (CMCs) to an Approved Application: Certain Biological Products, to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) ...

To embed, copy and paste the code into your website or blog: From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product liability and class action defense strategies for pharmaceuticals, medical devices and other FDA regulated products, it is often helpful to step back and review holdings that have affected the industry and may sha...