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Manufacturers Over-the-Counter Sales

American Conference Institute (ACI)

[Virtual Event] Advanced Legal, Regulatory and Compliance Forum on Over the Counter Drugs - February 26th, 9:00 am - 5:45 pm EST

A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more

Searcy Denney Scarola Barnhart & Shipley

Check Your Medicine Cabinet: FDA Announces Voluntary Recall for Over-the-Counter CVS Nasal Mist Due to Microbiological...

For the 26.9 million sufferers of sinus pain and pressure, nasal sprays are one of the most recommended and effective methods of relief. But one product, labeled as a CVS brand nasal mist, is being pulled off the shelves....more

Holland & Knight LLP

FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application

Holland & Knight LLP on

In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially...more

Mintz - Consumer Product Safety Viewpoints

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Locke Lord LLP

FDA Drops 19 Ingredients From the OTC Antibacterial Monograph: Antibacterial and Hand Soap Manufacturers Have One Year to Comply.

Locke Lord LLP on

On September 6, 2016, the Food and Drug Administration (FDA) published a final rule on the use of certain active ingredients which were proposed for inclusion in the Over-The-Counter (OTC) Consumer antiseptic washes portion...more

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