Day: July 15, 2021

Medical practice is regulated by the State medical boards not by FDA and FDA does not get to tell doctors what they can or can not prescribe to their patients, even if it is off label. A recent court ruling, although about a narrow case, confirms this principle once again. The case in hand was … Read more

Despite the media circus around FDA’s approval of Biogen’s Aduhelm, FDA’s decision is legal and permanent. And it will be repeated for other drugs in similar situations. The controversy around this decision is being fueled by misperceptions or misunderstanding of the FDA review process. The regulatory processes and FDA interactions that preceded the FDA decision … Read more