CVM effort to improve new animal drug submissions

Article Abstract:

Riviere Consulting and the US Food and Drug Administration's Center for Veterinary Medicine have formed an agreement to help improve the quality of submissions for new animal drugs. The partners will provide quality control services for drug sponsors who would like to have their new drug submissions examined before presenting them for regulatory review. Reviewers will identify and document data inconsistencies, poorly supported conclusions and other problems with submissions. This information will not only help to identify the difficult and confusing parts of drug submissions but will ultimately reduce the amount of time spent on regulatory reviews.

United States, Business services, not elsewhere classified, All Other Business Support Services, Administration of Public Health Programs, Business Services NEC, Bureau of Veterinary Medicine, Product development, Contracts, Services industry, Service industries, Business services, Administrative agencies, Government agencies, United States. Food and Drug Administration. Center for Veterinary Medicine., Riviere Consulting

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NOAH reflects on meds reviews

Article Abstract:

The future of the United Kingdom's agriculture and European veterinary medicine reviews were discussed at the National Office of Animal Health (NOAH)'s conference. Prime changes recommended by Review 2001 included the required use of a centralized route for all new chemical products. Recommendations also included classifying all products for animals that produce food as prescription-only medicines (POMs).

United Kingdom, Conferences, meetings and seminars, Animal health, National Office of Animal Health

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EU availability reform proposed

Article Abstract:

There are plans to reform the framework for approving medicinal products in the European Union (EU). The European Commission has set out its proposals on this issue. The impact on veterinary pharmaceuticals is examined.

Drugs & Pharmaceuticals, Pharmaceutical and Medicine Manufacturing, Drugs, Europe, Laws, regulations and rules, Pharmaceutical industry, Veterinary supplies industry

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