On June 23, 2023, FDA issued a draft guidance for industry – Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act (the Monograph FDR Guidance) – to fulfill another commitment agreed to in support …
FDA posted the last five “deemed final orders” under OTC monograph reform this week. All 33 of the final orders can now be found at OTCMONOGRAPHS@FDA. Under the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here), all final monographs …
Last week FDA checked off another item on its to-do list for implementing the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) OTC monograph reform provisions. As provided in the OMUFA Performance Goals letter, FDA issued draft guidance on the content and format of …
Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic …
As of the morning of March 1, the hotly anticipated Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee originally scheduled for March 20 has been cancelled. The March 20 Joint Meeting concerned the NDA for naloxone …
On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. All …
On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022). FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public …
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include …
Early Nov. 2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the …
On September 9, 2022, FDA published two notices regarding draft guidance related to labeling of drug products: a notice on the publication of a draft guidance on the Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products and …
Ten years in the making, a proposed rule was issued by FDA last week that has the potential to bring some prescription drugs that have not been able to gain an OTC approval to retail shelves at long last. Sponsors have been unable to overcome …
As readers of this blog may recall, in March 2020, as part of the CARES Act, the FDC Act was amended to include statutory provisions that (1) reform and modernize the way over-the-counter (OTC) monograph drug products are regulated in the United States and (2) …
Since March 2020 when the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law establishing section 505G of the Food, Drug, and Cosmetic Act (FD&C Act) (see our blog post here), the regulated community has been eager to engage with FDA …
The FDA announced last week that it intends to withdraw its guidance documents issued in March 2020 outlining temporary policies regarding the manufacture of hand sanitizers. Effective December 31, 2021, companies manufacturing hand sanitizers and alcohol for use in hand sanitizer under the temporary policies …
Many of us have been waiting not-so patiently for FDA to begin implementing the over-the-counter (OTC) monograph reform provisions of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here). While we are aware that behind the scenes the …
