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Drug Approval Standards

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

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.

US FDA Keeps Cessation As ‘Gold Standard’ For NRT Indication As Critics Question Its Worth

US FDA Keeps Cessation As ‘Gold Standard’ For NRT Indication As Critics Question Its Worth

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.

FDA, NIH Officials Encourage E-Cigarette NRT Innovation As Task Force Seizes Illegal Products

FDA, NIH Officials Encourage E-Cigarette NRT Innovation As Task Force Seizes Illegal Products

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

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.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

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.

US FDA Advisors Urge Faster Movement, mRNA Consideration, In Updating Pandemic Flu Vaccines

US FDA Advisors Urge Faster Movement, mRNA Consideration, In Updating Pandemic Flu Vaccines

The FDA’s vaccine advisory committee endorsed a new plan to update pandemic influenza vaccines “inter-pandemic,” but encouraged the agency to consider how to make the approach feasible for novel vaccine technologies.  

FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.

Sage NMDA Modulator Fails In Alzheimer’s Months After Parkinson’s Disappointment

Sage NMDA Modulator Fails In Alzheimer’s Months After Parkinson’s Disappointment

Dalzanemdor missed its primary endpoint in a Phase II Parkinson’s study, Sage announced, following April’s Phase II miss in Alzheimer’s. Phase II data in Huntington’s are still expected this year.

Scholar Rock Heading To Finish Line In SMA With Positive Pivotal Data

Scholar Rock Heading To Finish Line In SMA With Positive Pivotal Data

Phase III success positions Scholar Rock’s selective myostatin inhibitor for regulatory filings in early 2025. Analysts see a blockbuster opportunity for additive therapy in spinal muscular atrophy.

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.