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American Academy of Ophthalmology: The FDA Perspective

At AAO, FDA officials offered some very interesting insight into their regulation of ophthalmic drugs, including: No ophthalmology drugs will face an advisory committee review until they can be in person. No new ophthalmic drug approvals are likely soon. Review times are expected to be met. A court decision means a re-review of many approved drugs to get its dispenser approved, and future drugs with a dispenser will be regulated as a combination product. Trials of more than 5 patients must have a concurrent control. When two drugs are compared, they must be compared at the same dosing interval.

Monkeypox: The Unanswered Questions

The monkeypox outbreak is spreading rapidly worldwide, but there are a lot of unanswered questions. How is the virus transmitted? Can you get it from blood? Is the blood supply safe? Why isn’t there more effort to boost the vaccine supply? While monkeypox is not as fatal as HIV/AIDS or Covid-19, will it become the next pandemic? Here is a discussion of these questions and others that need attention if the mistakes of HIV/AIDS and the Covid-19 pandemic are to be avoided.

American Diabetes Association - Incretins

There was a lot of news at the ADA meeting on both drugs and devices, but one area that really stood out was the new incretins – approved and on the horizon. Some of these offer three advantages: lower HbA1c, weight loss, and easier dosing. There were also some very early but promising data on islet cell therapy for Type 1 diabetes.

White House Monkeypox Update

Biden administration officials, in a zoom conference with reporters, discussed the monkeypox outbreak and the actions they are taking to combat it, including increasing orders for vaccines and tests. However, they also left a lot of questions unanswered.

Virus Update

What virus should you be worried about today – coronavirus (Covid-19), monkeypox, adenovirus (hepatitis), bird flu, or the latest, Powassan virus? And there are others. For more than two years, coronavirus dominated the news, but recently several old – but serious – viruses have popped up in the news. Here is an update on each of these, with the key takeaways and things to know.

ASCO Preview

The American Society of Clinical Oncology (ASCO) meeting will take place June 3-7, 2022. Here is a report on what ASCO officials previewed for the meeting. They focused on equity, not the expected clinical trials.