SPOTLIGHT ON INITIATIVES

FDA’s drive towards increasing dialogue with the public to help patients with rare diseases

A recent press release from the FDA’s Office of Orphan Products Development (OOPD), in collaboration with the Center for Drug Evaluation and Research (CDER), announced the launch of web-based educational resources for patients and industry on FDA-related rare disease topics, the first of which was revealed…

China imposes restrictive regulation of genetic testing

China’s Food and Drug Administration (CFDA) has acted to impose regulatory constraints on the provision of clinical genetic tests. The announcement appeared vague as although the ban on prenatal DNA testing is unambiguously stated, it is not known whether the ban would apply to other…