Tag: FDA

FDA

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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Washington Focus

Federal Government and FDA Operating under Continuing Resolution as FY 2021 Begins

Federal Government and FDA Operating under Continuing Resolution as FY 2021 Begins

Oct. 5, 2020 – Because Congress has not yet passed a budget, the federal government began fiscal year (FY) 2021 on Oct. 1 operating under a Continuing Resolution (CR). The CR sets a new deadline of Dec. 11 for passage of the full budget, but a further extension until February or March is very possible. […]

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Washington Focus

Political Pressure on Federal Health Agencies Is Eroding Public Trust

Political Pressure on Federal Health Agencies Is Eroding Public Trust

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 […]

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Regulatory/FDA

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

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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Regulatory/FDA

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

June 9, 2020 – Speaking at a June 1 presentation to the Alliance for a Stronger FDA, FDA Commissioner Dr. Stephen Hahn said that despite criticisms of its performance during the COVID-19 pandemic, FDA’s “decisions [will] always be rooted in science,” and that lessons learned during the pandemic “will lead to permanent improvements at the […]

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Regulatory/FDA

As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds

As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds

May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]

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Regulatory/FDA

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

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Regulatory/FDA

FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment

FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment

March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]

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Regulatory/FDA

FDA Establishes Office of Oncologic Diseases to Streamline Drug Review Process

FDA Establishes Office of Oncologic Diseases to Streamline Drug Review Process

Nov. 8, 2019 – The FDA announced this week that it has reorganized its office that reviews applications for new and existing cancer therapies; its Office of Hematology Oncology Products has been renamed the Office of Oncologic Diseases (OOD) and has six divisions to accommodate a more streamlined drug review process, according to a Nov. […]

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