Firms' BioTemper, bare and Urea brand products, as formulated and labeled, are unapproved drugs that need approval through NDAs before being sold in US, FDA says in warning. Separate websites firm operates for each brand continues offering sales.
Scientific Solutions Global LLC's statement that it would stop distributing arnica-containing BioTemper topicals labeled for pain relief wasn't enough to keep the US Food and Drug Administration from warning it about crossing multiple OTC monograph boundaries.
The Carle Place, NY, firm also was outside the limits of an OTC monograph with its bare and Urea brand...
The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.
White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.
FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
HBW Insight speaks to Bayer Consumer Health's global strategy director for regulatory, medical, safety, quality, and compliance Emese Csoke about how least how widening access to self-care solutions can be balanced with equity with regards to affordability.
An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.
