Tag: FDA

FDA

6/4/21 Webinar: FDA Update: New leadership, initiatives and challenges


Friday, June 4, 2021, 12-1 pm ET What happens at the FDA is central to all health marketing and communications, controlling the flow of new drug approvals and regulating what manufacturers may say about their products. The agency has been through unprecedented challenges over the past two years. Now, with a new president and new (more…)

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Regulatory/FDA

HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration

HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration

April 19, 2021 – Calling the basis for proposed medical device exemptions from premarket notification (510(k)) requirements “flawed,” the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing exemptions for 83 class II devices and one unclassified device which were proposed Jan. 15 in the last few days […]

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Regulatory/FDA

HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit

HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit

March 22, 2021 – The Department of Health and Human Services (HHS) has postponed for one year the effective date of its Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule – put in place in the final days of the Trump administration – pending judicial review of a lawsuit filed March 9. In […]

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Regulatory/FDA

FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines

FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines

Feb. 8, 2021 – With growing concern about the spread of new COVID-19 variants, companies developing vaccine modifications will not have to “start at square one,” according to Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, M.D.. Because of early indications that the initial vaccines may have lower effectiveness against one or more of […]

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Regulatory/FDA

Woodcock to Take Helm While Biden Considers FDA Commissioner Choice

Woodcock to Take Helm While Biden Considers FDA Commissioner Choice

Jan. 18, 2021 – Under the Biden administration, longtime Center for Drug Evaluation and Research (CDER) director and FDA veteran Janet Woodcock, M.D., has been tapped to serve as the acting commissioner of the Food and Drug Administration (FDA) after current FDA Commissioner Stephen Hahn, M.D., stepped down on Jan. 20. Media reports suggest that […]

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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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Washington Focus

Rawson Previews Biden COVID-19 Approach and Vaccine Roll-out

Rawson Previews Biden COVID-19 Approach and Vaccine Roll-out

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 […]

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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

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

Nov. 2, 2020 – After 27 years with the Office of Prescription Drug Promotion (OPDP) – formerly called the Division of Drug Marketing, Advertising, and Communication (DDMAC) – OPDP Director Tom Abrams retired from the agency on Oct. 23 as the primary force behind today’s regulation of prescription drug advertising and promotion. Abrams’ leadership shaped […]

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Washington Focus

Coalition Webinar: Rawson’s Take on Post-election Healthcare Policy

Coalition Webinar: Rawson’s Take on Post-election Healthcare Policy

With a bitterly-contested campaign headlined by pandemic and recession nearly in the rear-view mirror and just days to go before the Nov. 3 election, communications and marketing professionals need to understand what the healthcare environment will look like when the dust settles. To help industry sort through the results and what they may mean for […]

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