JD Supra

Over-the-Counter (OTC) Monograph Reform Momentum Strong in 2019: Federal Legislation Update in the New 116th Congress

Recent developments in Congress deserve the attention of companies with over-the-counter drug products. Major legislation addressing comprehensive reform of the OTC drug monograph process, which ...
JD Supra

CARES Act Modernizes Over-The-Counter Drug Monograph Process

A complete overhaul to the over-the-counter (OTC) drug system quietly rode its way into law with the Coronavirus Aid, Relief, and Economic Security Act or the CARES Act (H.R. 748), along with several ...
ATM

Diebold earns award for new approach to OTC process

NORTH CANTON, Ohio -Diebold Inc. (NYSE: DBD), which provides self-service delivery and security systems and solutions, has earned the Alexander Hamilton Award, according to a news release. The award ...
FiercePharma

FDA moves toward a major overhaul of the way it approves OTC meds

The FDA, which has been talking for years about overhauling the over-the-counter (OTC) drug approval process, is taking steps it says will allow it to approve those products, and respond to safety ...
RAPS

FDA clarifies process for disputing OTC orders in final guidance

The US Food and Drug Administration (FDA) has finalized a guidance on how to conduct formal dispute resolutions (FDR) and administrative hearings to resolve scientific and/or medical disputes with ...