Regulatory/GMP Compliance

Oct 01, 2007
BioPharm International
Federal regulation of biologics began more than 100 years ago with the enactment of the Biologics Control Act of 1902. That act required licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and other similar products in order to prevent deaths from contaminated vaccines, as had recently occurred with the diphtheria antitoxin.
Oct 01, 2007
BioPharm International
Regulatory agencies have evolved along with the biotechnology industry to define quality standards.
Sep 01, 2007
BioPharm International
The new legislation authorizes the use of fee revenues for drug safety oversight and assessment throughout a product's lifecycle.
Aug 21, 2007
BioPharm International
By BioPharm International Editors
The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements.
Aug 21, 2007
BioPharm International
By BioPharm International Editors
The US Food and Drug Administration's Nanotechnology Task Force (www.fda.gov/nanotechnology/ nano_tf.html) has released a report recommending the agency develop guidelines and take other steps to address the benefits and risks of products, including drugs and medical technology, that use nanotechnology.
Aug 02, 2007
BioPharm International
Any endpoint considered appropriate to support approval, whether a surrogate or a clinical endpoint, must be supported by substantial evidence of effectiveness.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
With the advent of high-resolution mass spectrometers and highly sensitive MS instruments, vaccine characterization has entered a new phase.
Aug 01, 2007
BioPharm International
The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.
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