Tag: Jon Bigelow

Jon Bigelow

Data Privacy

Colorado Is Third State to Enact Data Privacy Law

Colorado Is Third State to Enact Data Privacy Law

July 19, 2021 – Colorado became the third state to enact comprehensive data privacy legislation – after California and Virginia – when Gov. Jared Polis (D) signed the Colorado Privacy Act into law on July 8. The Colorado law is similar to the two other states’ laws, in that it grants individuals greater control over […]

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Regulatory/FDA

CDER Approves 27 Novel Drugs in First Half of 2021

CDER Approves 27 Novel Drugs in First Half of 2021

July 12, 2021 – The COVID-19 pandemic did not slow down the drug approval process for the FDA’s Center for Drug Evaluation and Research (CDER) in 2020 – a year that saw CDER approve the second-highest number of new molecular entities (NMEs) – and that pace seems to be holding steady in 2021, with CDER […]

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Legislative

21st Century Cures 2.0 Seeks to Formalize Plans for ARPA-H

21st Century Cures 2.0 Seeks to Formalize Plans for ARPA-H

July 6, 2021 – The authors of the 21st Century Cures Act, which passed with bipartisan support in 2015, now want to build on its success with new legislation that would improve clinical trials, provide information and training for patients and caregivers, and fund President Joe Biden’s concept for an Advanced Research Projects Agency for […]

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DTC Advertising

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

June 29, 2021 – In the wake of the FDA granting a controversial accelerated approval for Biogen’s aducanumab (Aduhelm) – and Biogen’s decision to set the list price for the drug for Alzheimer’s disease at $56,000 per year despite equivocal evidence of efficacy – members of Congress are introducing drug pricing legislation, calling for hearings, […]

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Courts/First Amendment

ACA Survives SCOTUS Scrutiny, Latest in “String of Victories”

ACA Survives SCOTUS Scrutiny, Latest in “String of Victories”

June 17, 2021 – Today the U.S. Supreme Court dismissed a lawsuit claiming that the Affordable Care Act (ACA) is unconstitutional, leaving it as the law of the land. The Court ruled that the plaintiffs—a group of Republican attorneys general and two individuals—do not have legal standing to sue. According to Coalition for Healthcare Communication […]

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Data Privacy

4A’s Pepper: Data Privacy Issue Is “at an Inflection Point”

4A’s Pepper: Data Privacy Issue Is “at an Inflection Point”

May 17, 2021 – Widespread public concern over the security and privacy of personal data is putting increased pressure on state and federal legislators to regulate data collection, tracking and targeting, and today this issue is “at an inflection point about what we are going to start seeing from the federal government,” according to Alison […]

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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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