The US Food and Drug Administration’s 24 September proposed order to amend the OTC sunscreen drug monograph provides a first look at the new administrative – versus rulemaking – process for OTC drug review under reforms achieved through COVID relief legislation last year.
FDA’s Proposed Order For Sunscreens, A First Under OTC Reforms, Reprises 2019 Proposed Rule
As anticipated, the US FDA’s proposed order for sunscreens released on 24 September creates a bridge to the agency’s 2019 proposed rule before the CARES Act overhauled OTC drug review in March 2020.
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Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.
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Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.
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Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.
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The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
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The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
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US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
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Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.