HBW Insight introduces an ongoing feature with information on decisions by FDA on NDAs and ANDA for nonprescription drugs and on sNDAs for label and package changes for approved OTC products. Dr Reddys Laboratories' clearance to launch OTC nicotine replacement therapy lozenges in the US and revisions to Prilosec OTC and Monistat packaging were among FDA's s OTC-related decisions in January.
Editor's note: HBW Insight is launching an ongoing feature to provide information on decisions by the US Food and Drug Administration on new drug applications, including ANDAs, for nonprescription drugs and on supplemental NDAs about label and package changes for approved OTC products.
The FDA regularly publishes lists of its decisions on applications for new products and label changes across the US market...
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.
The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”
If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos
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.
Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.
HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.
