Over The Counter Drugs (OTC), Food and Drug Administration (FDA), Abbreviated New Drug Application (ANDA)

FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information

Sheppard Mullin Richter & Hampton LLP on 6/14/2023

On May 31, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations regarding prescription drug product labeling regulations. Under the new rule, each time a prescription drug products is...more

Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

Sheppard Mullin Richter & Hampton LLP on 4/27/2023

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the...more

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

King & Spalding on 1/10/2023

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

Dechert LLP on 10/19/2022

In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more

A New Day (And A New Acronym) For OTC Drugs

King & Spalding on 7/29/2022

The expansion of over-the-counter (“OTC”) drug options has been a long time coming. Advocates in various fora, including within the U.S. Food and Drug Administration (“FDA” or the “Agency”), have focused on the potential for...more

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

Hogan Lovells on 7/6/2022

On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more

The Not So Weaved Web: The Fate of CBD Products is in FDA’s Hands

Foley Hoag LLP on 8/20/2021

More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more

FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates

King & Spalding on 1/6/2021

Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for...more

OTC Monograph Reform: Key Takeaways and What Industry Can Expect

Mintz - Health Care Viewpoints on 6/10/2020

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more

Over The Counter Drugs (OTC) › Food and Drug Administration (FDA) › Abbreviated New Drug Application (ANDA)

"My best business intelligence, in one easy email…"