65 Food and Drug Law Journal, 317-346 (2010).
No medical intervention comes without risks. Certain risks may be grave, but will only occur in a fractional percentage of cases. When does the disclos...read more
65 Food and Drug Law Journal, 231-246 (2010).
An abbreviated pathway for the approval of biosimilar biological products, often called “follow-on biologics,” has been enacted into law as...read more
64 Food and Drug Law Journal 115-148 (2009).
Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or...read more
63 Food and Drug Law Journal 891-900 (2008).
By 2010, it is estimated that $10 billion in biologics will have lost patent protection and that generic versions, or “follow-on” biologics,...read more
63 Food and Drug Law Journal 321-374 (2008).
Gene therapy clinical research in the United States is regulated by FDA, and to a lesser degree, by NIH. During the period between 1999 and 2001, ...read more
62 Food and Drug Law Journal 805-830 (2007).
Recently, there has been a major breakthrough in cancer prevention in the form of the Human Papillomavirus (HPV) vaccine, Gardasil. This vaccine preve...read more
62 Food and Drug Law Journal 831-848 (2007).
Successive policy reports in Europe, the United States and elsewhere have concluded there is a need to enhance the regulatory regime for the evaluatio...read more
62 Food and Drug Law Journal 617-652 (2007).
Genetic testing has become an integral part of health care. With tests available to diagnose, treat, or predict more than 1400 diseases, obtaining an ...read more
62 Food and Drug Law Journal 257-304 (2007).
The statutory provisions defining human and veterinary biologics have very similar legislative histories. Their implementation, however, often has bee...read more
62 Food and Drug Law Journal 77-137 (2007).
The increasing use of biological products in medical care and their high costs have brought the issue of generic biologics to the fore. While FDA proba...read more