Only 6 Percent of Novel Drug Approvals in 2021 Involved Advisory Committee Meetings
May 23, 2020–The Food and Drug Administration’s (FDA’s) use of and reliance on advisory committees has declined sharply over the past decade,
Tag : Jon Bigelow
User Fee Legislation Markup Suggests Added FDA Regulatory Authorities
May 17, 2022 – Considering that the Food and Drug Administration (FDA) receives nearly half of its funding from medical product user fees, the
Clinical Trials Not Sufficiently Diverse – and Diversity Data Often Not Reported
May 9, 2022 – New analyses of clinical trials conducted in the United States and in Europe on potential new drugs found that not only were study
Medicare Advantage Plans May Promise More but Deliver Less
May 2, 2022 – Although Medicare Advantage (MA) plans often are touted for delivering more benefits at a lower cost than traditional Medicare, some
IQVIA Drug Spending Report: OOP Costs Increasing, but Net Prices Rising Below Inflation
April 25, 2022 – With drug pricing a hot-button issue as the midterm elections draw near, a recent report from the IQVIA Institute for Human Data
CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial
April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the
Biden’s 2023 Budget: Big Increases for FDA, CDC, Pandemic Preparedness
April 4, 2022 – The fiscal year (FY) 2023 budget proposed by President Joe Biden last week emphasizes fiscal restraint more than new, big spending
House Shines Spotlight on Accelerated Approvals, May Tie Legislation to PDUFA
March 21, 2022 – Pros and cons of the FDA’s accelerated approval pathway took center stage at a House Energy and Commerce Committee meeting held
Califf Confirmation in Jeopardy?
Feb. 7, 2022 – Although the nomination of Dr. Robert Califf to return as FDA Commissioner was advanced by the Senate House, Education, Labor, and
CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges
Jan. 4, 2022 – 2021 was a year of many healthcare challenges, but against this backdrop the Food and Drug Administration’s (FDA’s) Center for
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
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
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
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
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