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...FDA Commissioner Scott Gottlieb, MD, announced that the Center for Drug Evaluation and Research would be taking steps to modernize the organization and functions of the Office of New Drugs in order to address scientific and medical advances within the industry. The goal is to make the review process more integrated across science and regulatory expertise. Janet Woodcock, director of CDER, plans on elevating the role of FDA scientists and medical officers and providing these officers with more tools and support “to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”...Other changes will include the development of guidance documents, giving review staff more time with sponsors, and getting sponsors involved earlier in the development process. Engaging disease specialists, academic researchers, regulatory partners at other agencies, and patient groups is also a goal of CDER.

Picking apart biopharma’s protracted boom,…the vibe that getting drugs approved is simply much easier than it once was…. FDA has been green-lighting new drugs at an escalating rate for the past few years… some think the agency can go farther… 21st Century Cures Act,..contains a bevy of provisions designed to bring medicines to the market more quickly…The bill has faced staunch criticism from public health officials and media outlets, cautioning that there can be too much of a good thing, and improperly evaluated drugs can be just as dangerous to patients as no treatments at all.