Antibiotic Regulatory Affairs

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices etc. Regulatory affairs also have a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas: Ensuring that their companies comply with all of the regulations and laws pertaining to their business. Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices)

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

·         Pharmaceuticals

·         Medical devices

·         In vitro diagnostics

·         Biologics and biotechnology

·         Nutritional products

·         Cosmetics

·         Veterinary products

The CDC reports that antibiotic-resistant infections account for at least $20 billion in excess direct health care costs and up to $35 billion in lost productivity due to hospitalizations and sick days each year. The $1.2 billion investment increases funding for antibiotic resistance across the government in FY 2016.  For example, the Budget: Proposes an almost $1 billion investment in FY 2016 – nearly double the 2015 funding level –  for the Department of Health and Human Services (HHS), including:  More than $650 million across the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) to significantly expand America’s investments in development of antibacterial and new rapid diagnostics, and to launch a large scale effort to characterize drug resistance.  Earlier this year, NIH-supported scientists developed a novel technique for extracting powerful antibiotics from soil, including teixobactin: the first new antibiotic to be discovered in more than 25 years.  The FY 2016 investment increases support for this kind of innovative research and discovery.  More than $280 million at the CDC to support antibiotic stewardship, outbreak surveillance, antibiotic use and resistance monitoring, and research and development related to combating antibiotic resistance.  $47 million at the Food and Drug Administration (FDA) to support evaluation of new antibacterial drugs for patient treatments and antibiotic stewardship in animal agriculture. Nearly quadruples antibiotic research and surveillance funding at the Department of Agriculture (USDA) to $77 million. Increases funding at the Departments of Veterans Affairs (VA) and Defense (DoD) to $85 and $75 million, respectively, to address issues related to antibiotic resistance in healthcare settings.

  • National and International laws
  • Frame work of new laws (International understanding)
  • Different systems of operating laws (communication between market and officer desk)

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