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In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow. CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.
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Development of the model DFLs was a first for agency. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.
Participants in US FDA-commissioned CONFER study were scored on following label instructions for checking whether a potential patient has overdosed and administering a naloxone dose before calling for emergency help as well as on a "composite of cognitive walkthrough" of all those steps. Participants were in four groups: adult users of heroin and prescription opioids; those persons' friends and family members 18 years old and up; and separate groups of volunteers, 15- to 17-year-olds and adults.
Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated in Dublin but no longer owns, Analysts allowed President and CEO Murray Kessler. benefit of doubt he'll lead Perrigo out of prolonged slump when he joined firm in November after extensive executive experience with tobacco firms and in other consumer goods markets, but they're more circumspect about its chances of prevailing in Irish tax disagreement.
"Probably the worst offense" among Perrigo's problems is that before appointing President and CEO Murray Kessler in November, it had three CEOs since 2016, making him the fourth chief executive in three years, says Kessler. Perrigo's move to a self-care focus means "a broader emphasis on the wellness component of health and wellness" and opening its portfolio of products and categories to areas including nutraceuticals, oral care, probiotics, therapeutic skin care products and others.
With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action. The House has already cleared an OTC reform measure, as part of a pandemic preparedness bill, in the first days of the legislative session.
EllaOne manufacturer HRA Pharma supports British Pregnancy Advisory Service's call to scrap mandatory consultations for emergency contraceptives by switching the medicines from pharmacy-only sales to OTC. BPAS says there are “no risks which outweigh its use and it is considerably safer than many medicines sold straight from the shelf in the UK."
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