Tag: Jon Bigelow

Jon Bigelow

Washington Focus

Califf Answers Tough Questions, Sets Top Priorities During Senate HELP Hearing

Califf Answers Tough Questions, Sets Top Priorities During Senate HELP Hearing

Dec. 20, 2021 — Dr. Robert Califf, President Joe Biden’s nominee for the FDA Commissioner position, spent roughly two hours answering questions volleyed his way during last week’s Senate Health, Education, Labor, and Pensions (HELP) Committee’s hearing on his nomination. Califf’s answers, peppered with details, facts and figures, references to senators’ home-state concerns, anecdotes about […]

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Regulatory/FDA

CDER Steps in to Issue Warning Letters for Vaping Products Deemed Drugs

CDER Steps in to Issue Warning Letters for Vaping Products Deemed Drugs

Dec. 13, 2021 – Recent FDA Warning Letters calling out promotional claims made about vaping products are interesting in that they were issued not by the agency’s Center for Tobacco Products, but by the Center for Drug Evaluation and Research (CDER). “Although the FDA has been criticized for missing deadlines on approving or rejecting various […]

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Regulatory/FDA

FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

Dec. 6, 2021 – As the seemingly fast-spreading COVID-19 omicron variant begins to show up in the United States, the Food and Drug Administration (FDA) is taking measures now to meet any potential need for new diagnostics, vaccines and therapeutics to combat the next phase of the pandemic. On Dec. 2, President Joe Biden announced […]

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General

HHS: Pharmacists Can Administer COVID-19 Antivirals

HHS: Pharmacists Can Administer COVID-19 Antivirals

Nov. 29, 2021 –With little fanfare, the U.S. Department of Health and Human Services (HHS) recently moved to allow licensed pharmacists to dispense Food and Drug Administration (FDA)-authorized COVID-19 therapeutics directly to patients, without a physician prescription. This step, taken by publishing an amendment to a declaration under the Public Readiness and Emergency Preparedness Act, […]

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General

AMA To Tackle HCP Disinformation with New Policy

AMA To Tackle HCP Disinformation with New Policy

Nov. 22, 2021 – As the COVID-19 pandemic continues, the American Medical Association (AMA) is stepping up efforts to stop the dangerous spread of information, particularly when it comes from healthcare professionals (HCPs) who are using their licenses to validate the disinformation they are spreading. This scenario – where HCPs deliberately make false claims about […]

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Washington Focus

Califf Nominated as FDA Commissioner, Confirmation Fight Ahead, CHC’s Bigelow Says

Califf Nominated as FDA Commissioner, Confirmation Fight Ahead, CHC’s Bigelow Says

Nov. 15, 2021 – Many in the healthcare space are breathing a sigh of relief that President Joe Biden finally announced his nominee to be the new FDA Commissioner on Nov. 12: former FDA Commissioner Robert Califf, M.D. Although Coalition for Healthcare Communication Executive Director Jon Bigelow believes Califf will win Senate confirmation  for a […]

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Washington Focus

Build Back Better Act: Expanded Healthcare Coverage, FDA Funds, But So Far, No Drug Pricing Reforms

Build Back Better Act: Expanded Healthcare Coverage, FDA Funds, But So Far, No Drug Pricing Reforms

Nov. 1, 2021 – As Congress and the White House parry back and forth over specific provisions in President Joe Biden’s Build Back Better Act, the proposed legislation currently includes some expansion of healthcare coverage, new infrastructure money for the Food and Drug Administration (FDA), but no significant actions to tackle drug prices – yet […]

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Washington Focus

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Oct. 21, 2021—Nine months into President Joe Biden’s administration, he has still not nominated a candidate to take the helm at the Food and Drug Administration (FDA). Amid the COVID-19 pandemic and other pressing healthcare issues, the pressure is rising for a permanent FDA commissioner, but many of the frequently-named frontrunners for the position appear […]

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Regulatory/FDA

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

Oct. 11, 2021 – The Food and Drug Administration (FDA) will hold a virtual public meeting Nov. 2 to discuss the proposed changes it would like to make during the reauthorization process for the Biosimilar User Fee Act for fiscal years 2023 through 2027 (BsUFA III). The current legislation, BsUFA II, will expire in September […]

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Regulatory/FDA

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

Sept. 27, 2021 – In the midst of public scrutiny regarding clinical trial transparency, the Food and Drug Administration (FDA) and the United Kingdom’s Health Research Agency (HRA) recently took actions that may indicate their increased willingness to more closely monitor clinical investigators who do not report trial results in a timely manner. “Pharma, researchers, […]

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