Deborah Livornese

3 weeks ago | mondaq.com | Charlie Snow |Deborah Livornese |Ricardo Carvajal

HP Hyman, Phelps, & McNamara More Hyman, Phelps & McNamara, the largest FDA-focused law firm in the U.S., specializes in comprehensive legal solutions for companies regulated by the FDA and related agencies like the DEA, CMS, and USDA. The firm assists with regulatory compliance, product lifecycle management, marketing compliance, and due diligence, offering practical, responsive, and client-focused legal strategies.

3 weeks ago | thefdalawblog.com | Deborah Livornese |Ricardo Carvajal

On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States (link, link).

Jan 9, 2025 | mondaq.com | Deborah Livornese

As promised in the Fall Unified Regulatory Agenda, FDA issuedthe final rule to establish the pathway to obtain marketingapproval of a nonprescription drug product with an additionalcondition for nonprescription use (ACNU) on December 26, 2024,before the end of the calendar year. 89 Fed. Reg. 105288 (Dec. 26, 2024). Wedescribed the 2022 proposed rule and the ten-plus year historyleading up to its issuance in our blog post here.

Nov 11, 2024 | thefdalawblog.com | JP Ellison |Deborah Livornese

On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. FDA also noted that it has concluded that no safety signal was identified for oral PE at doses permitted under the monograph.

Oct 28, 2024 | thefdalawblog.com | John W.M. Claud |Deborah Livornese

On October 21, 2024, the Alliance for Natural Health USA (“ANH”), and Meditrend Inc., a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA. The genesis of this lawsuit is a disagreement over regulatory language and, more significantly perhaps, statutory interpretation.