United States: 5 Years for new pharmaceutical chemical entities, 3 years for new indications for pharmaceutical drugs, and 12 years for biologic products.

Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well.

This incident coupled with tetanus outbreak in Camden, New Jersey played an important part in initiating federal regulation of biologic products.

This separation technique is also particularly suitable for glycosylation analysis and quality assurance of glycoproteins and glycoforms in biologic medical products.

A major restructuring involves focusing on the pharmaceutical business and biologic products, along with productivity initiatives and cost-cutting and streamlining business operations through a multi-year program of on-going layoffs.

The program has successfully enabled the development and marketing of more than 350 drugs and biologic products for rare diseases since 1983.

The processing (often termed "manufacture," since the end result is deemed a biologic biopharmaceutical product) and the storage can occur at a collection center and/or a blood bank.

MassBiologics is the only publicly owned, non-profit FDA-licensed manufacturer of vaccine and other biologic products in the United States.

The concept of druggability is most often restricted to small molecules (low molecular weight organic substances) but also has been extended to include biologic medical products such as therapeutic monoclonal antibodies.

The design of biologic and biopharma products comes broadly under the BME-related (and overlapping) disciplines of biotechnology and bioengineering.