Worldwide: Food and Drugs Law

The Drug Enforcement Agency has begun conducting inspections of medical marijuana facilities following the rescheduling order, with regional offices reaching out to applicants and requesting detailed documentation on corporate structure, security protocols, and compliance procedures. While the process has unfolded smoothly thus far, operators must understand how federal DEA regulations layer onto existing state requirements to ensure swift processing of registration applications.

Accord BioPharma has secured FDA approval for ENNUMO, its second pegfilgrastim biosimilar referencing Amgen's NEULASTA, positioning the company as the only U.S. provider offering two distinct pegfilgrastim biosimilars alongside a short-acting G-CSF biosimilar. With eight pegfilgrastim biosimilars now approved by the FDA, the competitive landscape for these infection-reducing cancer treatments continues to expand. This approval strengthens Accord's biosimilar portfolio in the oncology supportive care market.

The FDA has proposed a new rule that would require foreign tobacco product manufacturers to register their establishments and submit product listings to the agency, aligning them with requirements already applicable to domestic manufacturers. While the rule is not yet final, it signals increased oversight of imported tobacco products and enhanced coordination between the FDA and U.S. Customs and Border Protection (CBP).