Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more
The US Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) on January 10 published much-anticipated FAQs implementing President Joseph Biden’s announcement last month to expand...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
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 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
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
Congress has reversed course and amended the Internal Revenue Code (“Code”) to provide that a health flexible spending account (“health FSA”), health savings account (“HSA”) and health reimbursement account (“HRA”) may...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
Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new authorities that will...more
For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief,...more
In response to the coronavirus pandemic, Congress recently passed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). President Donald Trump signed the CARES Act into law on March 27, 2020. Below is a...more
Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs...more
On March 27, 2020, President Donald Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (the CARES Act), a $2 trillion emergency relief bill, to help address the economic impact of the Coronavirus...more
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more
On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for Over-the-Counter (OTC) drugs. ...more
The CARES Act adopts several measures to help stabilize the healthcare system, address health care issues directly and indirectly related to the current pandemic and ensure future preparedness. It also allocates $100 billion...more
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 other significant reform...more
On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...more