regulatory/fda

1 min read 2022-05-31 19:50:43

OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians

May 31, 2022 – Understanding the tradeoffs among desirable and undesirable drug product characteristics that consumers and their treating

3 min read 2022-04-19 06:05:24

April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to

3 min read 2022-04-12 19:58:27

April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the

2 min read 2022-03-29 03:46:57

March 28, 2022 – As FDA Commissioner Robert Califf, M.D., determines how to fulfill his promise to re-examine the agency’s accelerated approval

4 min read 2022-03-15 03:58:09

March 14, 2021 – Nearly a month after being sworn in for the second time as Food and Drug Administration (FDA) Commissioner, Robert Califf, M.D.,

3 min read 2022-03-08 05:18:25

March 7, 2022 – Newly appointed Food and Drug Administration Commissioner Robert Califf, M.D., who is returning to the position he briefly held

2 min read 2022-02-28 23:24:06

Feb. 28, 2022 – Comments made in a video interview by CytoDyn Inc.’s former president and CEO suggesting that the investigational new drug (IND)

1 min read 2022-02-16 05:20:52

Feb. 15, 2022 – Dr. Robert Califf was confirmed to be the next Commissioner of Food and Drugs in a close 50-46 Senate vote today. In a sign of the

3 min read 2022-02-08 00:40:16

Feb. 7, 2022 – Although the nomination of Dr. Robert Califf to return as FDA Commissioner was advanced by the Senate House, Education, Labor, and

2 min read 2022-01-25 02:24:29

Jan. 24, 2022 – With the COVID-19 pandemic heading into year three, the Food and Drug Administration (FDA) faces ongoing challenges but continues

2 min read 2022-01-11 08:20:18

Jan. 10, 2022 – The Food and Drug Administration’s (FDA’s) ability to catch up with its inspection backlog caused by the COVID-19 pandemic is

1 min read 2022-01-04 20:34:10

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

1 min read 2021-12-14 04:03:19

Dec. 13, 2021 – Recent FDA Warning Letters calling out promotional claims made about vaping products are interesting in that they were issued not

2 min read 2021-12-07 08:24:55

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

1 min read 2021-10-26 04:41:56

Oct. 25, 2021 – Translating real-world data (RWD) into a standard format that the Food and Drug Administration (FDA) can process, review and