JD Supra3d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Las Vegas Sun7d
Alternative remedies prescribed as FDA weighs whether to pull plug on drug
Dr. Scott Manthei of the Nevada Ear and Sinus Institute has been advising patients against taking drugs like Sudafed for ...
The American Journal of Managed Care4d
Increased Interest in Advance Provision and Over-the-Counter Medication Abortion
An increased public interest and support for medication abortion following the federal Supreme Court ruling, particularly ...
JD Supra7d
The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’
The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some ...
Petros announces ‘conducive position’ with newly approved FDA OTC final rules
Petros Pharmaceuticals (PTPI) announces its conducive position in connection with the recently issued final rule, “Nonprescription Drug ...
New FDA rule to boost OTC drug access, but self-screening required
Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription Use (ACNU).
Yahoo Finance13d
Petros Pharmaceuticals Strategically Positioned to Benefit as Technology Leader from Newly Approved FDA OTC Final Rules
With the ACNU rule now approved and adopted, we are gratified to be at the forefront of the FDA's emerging requirements for Rx-to-OTC switches. Further, we believe our previous experience in ...
Healthline4d
Cancer Risk Prompts FDA Ban of Red Dye from Food and Ingested Drugs
The FDA issued a ban on the use of red dye No. 3 in food and beverage products and ingested drugs. The synthetic dye has been linked to cancer in animal studies and was banned more than 30 years ago ...
WKYC311d
New FDA rule to boost OTC drug access, but self-screening required
CLEVELAND — The FDA has approved what could be a groundbreaking new rule that could make more prescription medications available over the counter through a process called Additional Condition of ...
Kennebec Journal8dOpinion
Hilary Koch: The FDA’s Pinocchio problem
An experience with over-the-counter nasal spray showed Hilary Koch how drug manufacturers often rely on sins of omission.