Biologics regulation

BIO: Modify current law to eliminate inconsistencies between how traditional chemical and biotechnology drugs are regulated where these inconsistencies have no rational scientific basis.
FDA: Administrative reforms have eliminated the difference between approvals processes for "well-characterized" biologics and drugs and created a single application form for drugs and biologics.
Congress: Provided for in Kassebaum bill (S 1477).


: The establishment license application requirement should be replaced by a new requirement, applicable to all drugs (including biologics), that products be manufactured in accordance with good manufacturing practices and thereby apply the same regulations to biologics as currently applicable to drugs.