Tag: COVID-19

COVID-19

Regulatory/FDA

FDA at Turning Point: Kate Rawson Explains

FDA at Turning Point: Kate Rawson Explains

June 11, 2021 – The Food and Drug Administration (FDA) “is really central, not only to product approvals, but to what [medical product companies] can say in terms of marketing,” according to Prevision Policy Senior Editor Kate Rawson. Rawson, who spoke June 4 at a Coalition for Healthcare Communication (CHC) webinar, “What’s Ahead for the […]

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DTC Advertising

Major Health Advertisers Inadvertently Placing Ads on Misinformation Sites

Major Health Advertisers Inadvertently Placing Ads on Misinformation Sites

March 8, 2021 – Pharmaceutical companies and other healthcare stakeholders who utilize programmatic advertising are unintentionally placing ads that promote COVID-19 vaccines, vaccine distribution and safe pandemic practices on websites that are spreading false health information, according to a recent report from Newsguard. “Throughout the pandemic, many of the world’s largest and most trusted brands […]

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Regulatory/FDA

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding isolation and lack of employment and support services – the FDA’s Office of Prescription Drug Promotion (OPDP) has asserted the agency’s “ongoing commitment to combat inappropriate opioid use.” […]

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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

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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Washington Focus

Biden Plans Include Key Healthcare Appointments, ACA and, Maybe, Drug Pricing

Biden Plans Include Key Healthcare Appointments, ACA and, Maybe, Drug Pricing

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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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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Washington Focus

Biden Gears Up After Win, Announces COVID-19 Advisory Board

Biden Gears Up After Win, Announces COVID-19 Advisory Board

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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Regulatory/FDA

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

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 […]

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