Newsletter - July 15, 2021
FDA’s Aduhelm Decision is Permanent, Aduhelm will Not be an Exception
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...Read More
FDA Cannot Regulate Off-Label Use by Physicians: Decisive Court Decision
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
FDA’s Aduhelm Decision is Permanent, Aduhelm will Not be an Exception
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...Read More
FDA Cannot Regulate Off-Label Use by Physicians: Decisive Court Decision
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
