Dec. 21, 2020 – As President-elect Joe Biden takes office in January 2021, understanding what could change and what could remain the same at the FDA is important, according to Nancy Bradish Myers, president and CEO of Catalyst Healthcare Consulting Inc. Myers, who has held key positions at the FDA and in industry, spoke at […]
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Dec. 7, 2020 – President-elect Joe Biden announced on Dec. 7 his plans for filling key public health positions, including nominations for California Attorney General Xavier Becerra to be the next secretary of Health and Human Services and Dr. Rochelle Walensky, currently an infectious disease specialist at Massachusetts General Hospital, to become director of the […]
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Nov. 30, 2020 – Job one for President-elect Joe Biden is the response to the COVID-19 pandemic, which will represent a “marked difference in energy and tone” than that offered by the current administration and likely will include a new FDA Commissioner as well as the roll-out of COVID-19 vaccines, according to Kate Rawson, senior […]
Read more Nov. 9, 2020 – Just two days after his election victory became apparent, President-elect Joe Biden signaled his number one priority by naming the co-chairs and membership of his COVID-19 Advisory Board. “Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science […]
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Oct. 12, 2020 – The FDA’s Office of Prescription Drug Promotion (OPDP) enforcement efforts are picking up steam following a slow start – just one enforcement letter issued between January 2020 and July 2020 – with two recent Warning Letters resulting from complaints through the agency’s Bad Ad Program. In a Sept. 22 Warning Letter […]
Read more Sept. 14, 2020 – As the COVID-19 pandemic persists and the race for a vaccine to prevent contracting the virus heats up, there is a great deal of misinformation circulating about treatments and the majority of Americans are concerned that political pressure from the Trump administration will lead the Food and Drug Administration to approve […]
Read more Aug. 20, 2020 – The Food and Drug Administration’s (FDA’s) ability to approve new drugs while juggling new responsibilities during the COVID-19 pandemic appears to be exceeding expectations, with the agency approving 36 novel drugs to date in 2020, an increase from the 24 new molecular entities (NMEs) approved by this date in 2019 (with […]
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July 20, 2020 – The Trump administration instructed hospital systems and providers last week that they should no longer report data on COVID-19 cases, hospitalizations, deaths, positive test results, etc. to the Centers for Disease Control and Prevention’s (CDC’s) National Healthcare Safety Network site, and instead should send this information to a newly launched data […]
Read more June 29, 2020 – After being scrutinized for years regarding drug pricing issues, the biopharma industry is enjoying a boost in public opinion during the COVID-19 crisis. However, that boost may slowly be fading as lawmakers and the public continue to be skeptical of the industry, as evidenced by two bills introduced in the House […]
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June 15, 2020 – The COVID-19 pandemic has brought increased use of telemedicine and group conferencing platforms, as well as prompted talk of using cellphones to do contact tracing, but this uptick in using technology in new and expanded ways also has increased the risks to personal data. Unfortunately, at a time when consumer data […]
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