Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.
The OTC monograph system is at risk of obsolescence unless FDA moves some ingredients approved through new drug applications into monographs, which would expand competition for manufacturing those products, according to experts.
Many monograph OTCs largely are overshadowed and outsold in the marketplace by NDA products, either Rx-to-OTC switches or other drugs...
The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.
The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.
The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.
In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
