Patent Access& Intellectual property& FDA Regulations

A patent is an arrangement of select rights conceded by a sovereign state to an innovator or appointee for a constrained timeframe in return for point by point open divulgence of a creation. An innovation is an answer for a particular mechanical issue and is an item or a procedure. Licenses are a type of protected innovation. Regulatory affairs  is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory Affairs  is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities.

U.S. Food and Drug Administration’s Centre for Drug Evaluation and Research (CDER) announced the approval of plans to elevate the Office of Generic Drugs (OGD) to an office that reports directly to the centre director.  This reorganization will strengthen OGD’s operations and enable the office to meet the evolving needs of generic drug review. Generic prescription drugs make up 84% of prescriptions filled in the United States and provide affordable access to treatments for many patients and consumers. The American public depends on FDA to ensure that generic drugs perform clinically in the same way as their brand name counterparts.  The OGD reorganization is a critical and necessary step in recognizing the importance of generic drugs to public health and our national economy

  • Lifecycle management of drug products
  • Patents and disputes case studies
  • Identification techniques adulterated and misbranded drugs
  • FDCA (Federal Food, Drug, and Cosmetic Act )
  • Exemption in prescription and OTC drugs
  • Environmental health hazards

Related Conference of Patent Access& Intellectual property& FDA Regulations

November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria
August 20-22, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan

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