Running Head: REGULATORY PROCESS FOR BIOLOGICAL
Regulatory Process for Biological
I am a primary reviewer in, The Centre for Biologics Evaluation and Research (CBER)
one of the U.S main six centers for Food and Drug Administration (FDA) which is part of the
U.S. Department of Health and Human Resources. My organization, according to the section 351
of the public health service Act regulates the permitting of the biological products that are traded
in different states in the United States under applicable federal law protects and advances the
human health by ensuring that the products are safe, effective and available to all the citizens
who need them my organization also provides information to the public to promote the safe and
effective use of the biological products, CBER has the authority to deny licensure, suspend or
cancel if the manufacturer of the products does not comply with the requirements. A certain
biotech company is applying for a viral vector hemophilia therapy license from my organization.
The company is using an adeno-associated virus vector expressing the factor VIII gene which
transduces cells and persists within the cell. The company has performed clinical trials to
demonstrate the validity and efficiency of its gene in Europe and in the United States.
Possibility for a meeting between the U.S regulators and the applicant of the licensing
Based on the information provided by my organization FDA’s Centre for Biologics Evaluation
and Research (CBER) website, it is clear that the organization officials hold meetings,
REGULATORY PROCESS FOR BIOLOGICAL
conferences and various workshops about various biologics with the main aim of educating the
general public and seek the opinions from the interested members of the public. The minutes a...