Todd Rundgren’s 1978 classic, “Can We Still Be Friends?” (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative...more
Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more
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
The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more
By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as...more
On September 20, 2021, the Food and Drug Administration (FDA) announced that as part of the Over-the-Counter (OTC) Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), it had posted an...more
As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more
On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more
On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC)...more
On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more
On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech...more
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
On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the Over-the-Counter (OTC) Drug Monograph User Fee...more
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
On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program. That user fee program was an addition...more
With only a few days left in 2020, a year that has been mostly focused on the Food and Drug Administration’s (FDA) Coronavirus pandemic response, the agency has taken another step to further implement the provisions of the...more
On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more
The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to the Food and Drug Administration’s regulation of over-the-counter (OTC) drugs in the United States. We previously...more
With all of the challenges to public health during the Summer of 2020, there is some comfort in the Centers for Disease Control’s (CDC) recommendation that fresh air and sunshine is beneficial. For decades, sunscreen has been...more
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
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
In March 2020, the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to modernize the regulation of over-the-counter (OTC) drugs in the United States....more
Last month, Congress enacted significant reforms to the over-the-counter (“OTC”) drug review process. The reforms, enacted as part of the “Coronavirus Aid, Relief, and Economic Security Act” (“CARES Act”), change...more