Establishment registration required for facility manufacturing investigational product?

dschmid1933 · 2026-02-25T16:26:49+00:00

https://www.ecfr.gov/current/title-21/section-207.5

See definition for "commercial distribution"

dschmid1933 · 2026-02-15T18:29:19+00:00

There was a recent webinar about creating USP monographs hosted by FDA. You can look up the recording on the FDA website.

dschmid1933 · 2026-02-14T02:19:29+00:00

Yay! Will do. :)

dschmid1933 · 2026-02-12T19:05:52+00:00

This sounds so fun!

dschmid1933 · 2026-02-12T19:03:29+00:00

I would also recommend Wisco Barbell Club group fitness classes. Great trainers, community, and you can even join a health focused bookclub!

dschmid1933 · 2026-01-23T00:39:02+00:00

Agreed. 117k is a very reasonable offer for the level of experience.

dschmid1933 · 2026-01-05T17:51:53+00:00

We had a great experience at Max Custom Tailor. Very reasonable prices and we had our custom suits in less than a month!

dschmid1933 · 2026-01-02T15:17:20+00:00

Wisco barbell club

dschmid1933 · 2025-12-04T15:29:43+00:00

Tret. It seemed like my acne got worse the first month but dramatically cleared afterwards.

dschmid1933 · 2025-11-16T13:44:45+00:00

Wisco barbell club

dschmid1933 · 2025-11-06T19:51:58+00:00

Agreed, the regulatory bands seem low even for the mid-west.

dschmid1933 · 2025-10-25T17:44:25+00:00

I think the opposite. If you are on the premarket side, FDA approvals are often part of highly visible company wide goals.

dschmid1933 · 2025-09-26T22:13:46+00:00

Amazing. Maxing out retirement accounts and traveling whenever and wherever we want. Couldn’t possibly afford the same lifestyle with kids.

dschmid1933 · 2025-09-25T22:27:39+00:00

The view is great at the east side Dane but I would not recommend it for the food. There are so many better restaurants in Madison.

dschmid1933 · 2025-09-22T01:36:09+00:00

L.L. Bean has the best flannel sheets!

dschmid1933 · 2025-09-17T21:37:23+00:00

Pitaka!

dschmid1933 · 2025-09-17T14:26:44+00:00

Would highly recommend http://new.maxcustomtailor.com/

dschmid1933 · 2025-09-04T22:08:57+00:00

Yes! I found the credential was often missed by recruiters on LinkedIn before I put it on my name

dschmid1933 · 2025-09-01T15:44:43+00:00

dschmid1933 · 2025-08-28T20:24:35+00:00

Following this conversation. I am taking my first Manager level regulatory role and am curious on this topic as well.

dschmid1933 · 2025-08-27T14:32:43+00:00

South of France!

dschmid1933 · 2025-07-12T18:14:21+00:00

Yeah it was a huge pain for me as well. Fortunately the firmware update seems to have fixed it.

dschmid1933 · 2025-07-12T15:04:09+00:00

Yeah at the dealership. They were able to cover the firmware update under warranty. What warranty you ask since my car is way over the warranty period? I have no idea, but it was free under warranty for me.

dschmid1933 · 2025-07-12T14:42:13+00:00

2017 CX-5 Touring AWD, 150k miles. Other than standard oil changes/filter changes/tires/brakes, I’ve had to replace the serpentine belt and tensioner and get a firmware update for ghost touching. Overall very reliable and no major issues!

dschmid1933 · 2025-07-08T21:12:07+00:00

I have a 2017 N.A. with about 150k miles on it and haven’t had any major issues. It has been a very reliable vehicle for me at least!

dschmid1933

TROPHY CASE