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Petros Pharmaceuticals Reports Positive Results in an Initial Cohort Two-Arm Self-Selection (Phase 2-Equivalent) Study for STENDRA(R) (avanafil) as it Pursues OTC Status

02.04.2024 - Nitrate patients subgroup demonstrated 100% correct self-selection when utilizing the web app technology with the drug facts label compared to 40% when using drug facts label alone (among 86% vs. 56% of all users) underscoring the significant ... Seite 1
Petros Pharmaceuticals Inc Drug Administration Petros Pharmaceuticals Drug Facts Label Petro President Chief Commercial Officer

Petros Pharmaceuticals Announces Two Upcoming FDA Meetings to Review Progress and Path Forward for S

FDA requests meeting to review the Company's technology component and discuss further development and requirementsNEW YORK, NY / ACCESSWIRE / January 24, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development pr...
Jules Abraham Drug Administration Petros Pharmaceuticals Petros Pharmaceuticals Inc Endo Pharmaceuticals Exchange Commission

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FDA pushes OTC switch for naloxone, continuing trend toward making more drugs available without a prescription | Hogan Lovells

The U.S. Food and Drug Administration (FDA) recently issued the Federal Register notice โ€œSafety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription...
Robertm Califf Hogan Lovells Opioid Public Health Emergency Emergent Biosolutions Inc Certain Naloxone Hydrochloride Drug Products Nonprescription Use

NCPA sends comments, concerns to FDA on ACNU proposed rule

NCPA submitted comments to FDAโ€™s proposed rule, Nonprescription Drug Product With an Additional Condition for Nonprescription Use. According to the proposed rule, under an ACNU, a drug manufacturer must ensure that patients can appropriately self-select a medication.
United States National Alliance Of State Pharmacy Associations National Association Of Chain Drug Stores American Pharmacists Association American Society Of Consultant Pharmacists Nonprescription Drug Product With
Source: ncpa.org

NCPA, others call for delay on FDA's nonprescription drug proposed rule

NCPA joined APhA, ASCP, NASP and NACDS in signing onto a letter calling for FDA to extend the comment deadline for the Nonprescription Drug Product With an Additional Condition for Nonprescription Use proposed rule by at least 90 days to allow stakeholders to appropriately respond. Since comments are due Oct. 26, the extension, if granted, would allow comments to be submitted until about Jan. 26.
Nonprescription Drug Product With Additional Condition Nonprescription Use
Source: ncpa.org

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