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…D enrollee’s copay for tafamidis, subject to certain eligibility criteria, including financial need. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of…
…coverage of “usual patient care” in qualified clinical research. “Usual patient care” is defined as routine clinical services and investigational clinical services in clinical research when the investigational clinical services…
…Pfizer would directly cover nearly all of a Medicare Part D beneficiary’s copay for tafamidis, subject to certain eligibility criteria, including financial need. Eligible patients would be responsible for only…
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published a Final Rule increasing initial registration and renewal fees for all registrants. 77 Fed. Reg. 15,234 (Mar. 15,…
…the common pitfalls. Although nearly a year has passed since the final guidance document for the eCopy Program for Medical Device Submissions (the “eCopy Guidance,” we previously blogged on the…
…change in an amendment (See, e.g., Alza Corp. et al. v. Impax Laboratories Inc. et al., Case No. 1:10-cv-01024 [here]; Alza Corp. et al. v. Impax Laboratories, Inc. et al.,…
…May 23, 2017, The White House Office of Management and Budget released President Trump’s Fiscal Year 2018 Budget. We pored over the volumes of analytical perspectives, supplemental materials, and what…
…days after publication of the final rule. This means that the initial report due on March 31, 2013 would cover only a portion of CY 2012. The reporting requirement would…
…diversity in clinical trials. This guidance was finalized in 2020. The COVID-19 pandemic temporarily halted many clinical trials and left an indelible mark on clinical trial recruitment. The challenges of…
…Avadel has invoked in this case.” The FTC Brief further provides a textual argument based on the statutory language. Because the statute states patents covering methods of using a drug,…
…already in a final packaged form before placement in the outer overpackaging. As we reported previously, the new law also provides for fees for OTC monograph order requests (OMORs). Fees…
…§ 314.94(a)(8)(iv), interpret these provisions to also allow changes due to an aspect of labeling protected by patent or exclusivity. The difference at issue here is the fact that Vanda’s…
…co-chair of the Congressional Cannabis Caucus, co-sponsored the amendment to H.R. 7617, the Department of Defense Appropriations Act of 2021, with Representatives Tom McClintock (R-California), Eleanor Holmes Norton (D-District of…
…of federal law bars the inventor from marketing the invention for sometimes half—or even more—of the patent life. That is, federal regulatory requirements “distort” the patent. . . . This…
…times the number of PMAs, PDPs, Panel-Track PMA Supplements; 8 times the number of 510(k) premarket notifications; and 60 times the number of de novo submissions. This would require a…