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 ...
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).
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 ...
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 ...
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 ...
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 ...
Nasdaq13d
Petros Pharmaceuticals Positioned To Lead Rx-to-OTC Switch With New FDA Rule
Petros aims to be a innovator in this emerging market by helping companies meet the FDA's requirements for Rx-to-OTC switches. "We are excited to be at the forefront of this emerging sector," said ...
pulmonologyadvisor5d
Over-the-Counter HIV Test Approved for Adolescents
The Food and Drug Administration has approved the OraQuick® HIV Self-Test to include individuals 14 years of age and older.