As a follow-up to our previous article on the CREATES ACT, other types of clinical trials for which we seek comparator drugs are mostly for head-to-head comparisons for new indications, or non-inferiority trials, and generally fall under 505(b)(1),... Read More
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The refusal to provide comparator products violates federal and state antitrust laws and the CREATES Act. Although the Supreme Court has expressed caution about imposing antitrust liability based on a monopolist’s unilateral refusal to deal, the... Read More
Biotech Companies | Blogs & Articles | Life Sciences | Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

As Coronavirus (COVID-19) cases continue to plateau and as the nation experiences the benefit of social distancing, the focus has quickly turned to the development of a vaccine.  Promising Vaccines Despite the substantial cost of developing,... Read More
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