19 Dec, 2022 FDA Denies Requests for Revocation of EUA for Covid Vaccine for Use in Individuals 5-11 and 12-17 Years of Age By Melissa Gilmore Jarred Reiling Keo Shaw The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
27 Jun, 2022 FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility By Bethany Hills Hilary Hoffman After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
14 Mar, 2022 Breaking taboos: the ascension of FemTechs in the healthcare market By Bruna Rocha Victoria Cristofaro International Women's Day, celebrated every March 8, focuses on the achievements of women over the years in the cultural, political and...
04 Mar, 2022 The beginning of the end: FDA details roadmap to terminating COVID-19 EUAs and enforcement policies for medical devices, PPE By Melissa Gilmore In late February, 2022 the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical...
08 Feb, 2022 An analysis of the effect of drug pricing provisions in the Build Back Better Act on pharmaceutical innovation By Kirsten Axelsen Having previously examined the impact of implementing international reference pricing in the United States, Charles River Associates (a...
17 Nov, 2021 Assessing the value of medicine for diverse patients: Implications of a QALY approach for health disparities By Kirsten Axelsen Momentum and debate about the application of cost-effectiveness analysis to determine the value and prices of prescription drugs in the...
02 Mar, 2021 Telehealth - a white hot M&A market? By Moritz von Hesberg The global outlook for M&A in the digital health and particularly the telehealth sector has never been brighter than today. Telehealth’s...
09 Feb, 2021 Prohibition Partners: Interview for the the North American Cannabis Report By Robert Fonn This week I was kindly asked by Prohibition Partners - a leading consultancy focused on the global cannabis industry, to be interviewed...