Tag: Nancy Myers

Nancy Myers

Regulatory/FDA

Myers: Data Will Drive Califf’s Decisions at FDA

Myers: Data Will Drive Califf’s Decisions at FDA

March 14, 2021 – Nearly a month after being sworn in for the second time as Food and Drug Administration (FDA) Commissioner, Robert Califf, M.D., has a lot on his plate, including the ongoing COVID-19 pandemic — and lessons learned about processes and the harms of misinformation – as well as a call for clinical […]

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Regulatory/FDA

Myers: FDA Priorities Persist Amid Challenges

Myers: FDA Priorities Persist Amid Challenges

Jan. 24, 2022 – With the COVID-19 pandemic heading into year three, the Food and Drug Administration (FDA) faces ongoing challenges but continues to work on four primary agency priorities, according to Nancy Bradish Myers, president of Catalyst Healthcare Consulting, who spoke at a Jan. 21 Coalition for Healthcare Communication webinar, “A New Start for […]

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Regulatory/FDA

Despite Strain on Resources During Pandemic, CDER Approves 53 Novel Drugs in 2020

Despite Strain on Resources During Pandemic, CDER Approves 53 Novel Drugs in 2020

Jan. 11, 2021 – When considering all of the COVID-19 challenges the FDA faced in 2020, it is noteworthy that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year, the second highest number of novel drug approvals in the past 10 years. In a forward to CDER’s 2020 report on […]

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Regulatory/FDA

Myers: What the FDA Might Look Like Under Biden

Myers: What the FDA Might Look Like Under Biden

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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12/16/20 Webinar: What’s next for the FDA in the Biden administration?

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Dec. 16, 2020, 12-1 pm ET The FDA entered 2020 with a new Commissioner, then soon faced unusual scientific challenges—and unprecedented political attacks—as it worked to cope with the COVID-19 pandemic. Yet, even as its credibility took some hits, the FDA has moved forward aggressively to establish a streamlined process for evaluating COVID-19 vaccines and (more…)

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Regulatory/FDA

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

July 1, 2019 – Among the issues on the Food and Drug Administration’s (FDA’s) plate for the remainder of 2019 are implementing organizational changes, securing appropriations funding for 2020, modernizing clinical trial design and regulating promotional messaging, according to Nancy Bradish Myers, president, Catalyst Healthcare Consulting, who spoke at the recent Coalition for Healthcare Communication […]

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Regulatory/FDA

FDA After Gottlieb: Will Sharpless Stay the Course?

FDA After Gottlieb: Will Sharpless Stay the Course?

June 3, 2019 – In the wake of Dr. Scott Gottlieb’s recent departure from the FDA and the appointment of Acting FDA Commissioner Dr. Ned Sharpless, industry can expect Sharpless to continue many of the initiatives and action plans established by Gottlieb, who was one of the most activist FDA commissioners in FDA history, according […]

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