Tag: Jon Bigelow

Jon Bigelow

Regulatory/FDA

FDA Clamps Down on Company for Failing to Submit Clinical Trial Data to ClinicalTrials.gov

FDA Clamps Down on Company for Failing to Submit Clinical Trial Data to ClinicalTrials.gov

May 3, 2021 – Although the Food and Drug Administration (FDA) has issued more than 40 “Pre-Notices of Noncompliance” to companies to encourage voluntarily compliance with a federal requirement to submit all clinical trial data to the ClinicalTrials.gov database, last week the agency issued its first “Notice of Noncompliance” to Acceleron Pharma for not complying […]

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Regulatory/FDA

FDA Cracks Down on “FDA-registered” Device Certificate Claims

FDA Cracks Down on “FDA-registered” Device Certificate Claims

March 29, 2021 – The FDA does not issue certificates to medical device companies that register their facilities with the agency, nor does the registration of a device facility denote that products made in that facility are approved, cleared or authorized by the FDA, so a recent increase in the number of companies selling devices […]

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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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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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Courts/First Amendment

Maryland Sued Over Digital Ad Tax

Maryland Sued Over Digital Ad Tax

Feb. 19, 2021 – On Feb. 18, four trade groups – the U.S. Chamber of Commerce, the Internet Association, NetChoice, and the Computer and Communications Industry Association, whose members include tech giants Amazon, Facebook and Google – filed a lawsuit in the U.S. District Court for the District of Maryland stating that Maryland’s new digital […]

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Legislative

Maryland Legislature Overrides Gov. Hogan Veto, Enacts Digital Advertising Tax

Maryland Legislature Overrides Gov. Hogan Veto, Enacts Digital Advertising Tax

Feb. 15, 2021 – The Maryland House and Senate voted last week to override Gov. Larry Hogan’s May 2020 veto and enact the nation’s first tax on digital advertising, a move that other states are in the process of considering in light of a backlash against big tech companies and significant budget shortfalls as the […]

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Washington Focus

Biden’s “Health Care Day” Previews Next Steps

Biden’s “Health Care Day” Previews Next Steps

Feb. 1, 2021 – President Joe Biden presented his current vision for the state of the nation’s healthcare during last week’s “Health Care Day,” one of several themed presentations his administration is holding to roll out key policies. Describing Executive Orders that he signed in the healthcare arena, Biden stated that the best way to […]

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Washington Focus

Senate Delay in Confirming HHS Secretary Could Stall Biden’s Healthcare Plans

Senate Delay in Confirming HHS Secretary Could Stall Biden’s Healthcare Plans

Jan. 25, 2021 – As of Jan. 25, and five days after the inauguration of President Joe Biden, the Senate has not yet scheduled confirmation hearings for Xavier Becerra, Biden’s nominee for Secretary of the Department of Health and Human Services (HHS). Any delay in his confirmation will cause a leadership gap at a critical […]

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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

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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