notlob

9 ms·

31.
by notlob 8y ago
What sort of E&O coverage is needed on projects like this?
32.
Tesla workers say factory paint shop has had multiple fires, causing problems(cnbc.com)
2 points by notlob 8y ago|0 comments
33.
by notlob 8y ago
They are I think referring to first-sale doctrine.
34.
by notlob 8y ago
> This is missing my pet step: doing the literature review. One of the earliest, most important, and most useful lessons I learned from a senior grad student: "a day in the library can be worth a week at the bench."
35.
FDA to start naming names of pharma companies blocking cheaper generics(arstechnica.com)
4 points by notlob 8y ago|0 comments
36.
by notlob 8y ago
These are design patents, not utility patents. Chapter 1500 of the MPEP is the relevant reference, and in particular, 1502 distinguishes between design and utility patents. > In general terms, a “utility patent” protects the way an artic
37.
by notlob 8y ago
I’d also like to add that the claimed elements appear in solid lines; broken lines are to show visible environmental structure and are not part of the claim.
38.
by notlob 8y ago
I would suggest taking a more proactive approach in your relationship with the FDA, perhaps hiring an experienced consultant to either help you work with the FDA (the new "Pre-Cert" program might be worthwhile) or dial back your m
39.
by notlob 8y ago
Can you speak a bit about how this is regulated? Are you working with the FDA Digital Health group?
40.
by notlob 9y ago
For someone in the medtech space, it's been interesting to see how loosely (not at all?) marketing is regulated in automotive and tech in general. Were the FDA regulating automotive, there is absolutely no way that Tesla's drivin
41.
by notlob 9y ago
It seems premature to ask the question in the title at this juncture, doesn't it? DoJ is still investigating Holmes.
42.
Elon Musk Is the Henry Ford of His Age. That's Bad(bloomberg.com)
2 points by notlob 9y ago|1 comments
43.
New report highlights limitations of Cruise self-driving cars(arstechnica.com)
2 points by notlob 9y ago|2 comments
44.
by notlob 9y ago
At UIUC biochemistry is offered through Molecular and Cellular Biology. It's a good program but distinct from Chemistry. Next semester sounds like sophomore fall, which would be on schedule for chemistry majors as well as biochem maj
45.
by notlob 9y ago
This is a misstatement of what the biochemistry coursework I am familiar with looks like. Biochem, when offered as an undergrad program, is offered through the biology department and has a number of standard biology department requirements
46.
by notlob 9y ago
What does “cognitively more demanding“ mean?
47.
by notlob 9y ago
That link doesn’t address my question. It says he works at SpaceX and he works at Tesla, not the nature of the work.
48.
by notlob 9y ago
He manages engineers, and he would seem to be quite effective at it (a rarity!), but being a highly technical manager isn’t the same as performing engineering work. Do you have a specific example in mind?
49.
by notlob 9y ago
It’s a risk/benefits balance. Rhinovirus 39 is very low risk, especially under controlled conditions. Loneliness in the developed Western world is a growing problem, so gaining a better understanding of what impact it will have has cle
50.
by notlob 9y ago
“Then, the researchers gave each participant an intranasal live-virus vaccine against rhinovirus 39...” Joking aside, what part of this seems improperly managed by the IRB?
51.
by notlob 9y ago
Will this be self-hosted? Also, why FDA first instead of CE?
52.
by notlob 9y ago
Drug company employee salaries and overhead also keep pace with inflation, better than academic salaries. I don’t understand your point. A biologic production line requires extensive upkeep: it is a living product. Costs all around are high
53.
by notlob 9y ago
I don’t have specific knowledge on Humira or its biosimilars, but $40 is more reasonable. To be specific, Humira was developed from research by BASF Bioresearch (bought by Abbott) and a research consortium in the UK, so credit to the UK tax
54.
by notlob 9y ago
It’s perhaps analogous to how list prices for college tuition aren’t necessarily reflective of what people actually pay. It’s a complex system and the price increases are used in part to negotiate with the intermediaries like PBMs. Biologic
55.
by notlob 9y ago
> For a drug that costs literally pennies per dose to manufacture. Pennies per dose for a biologic?
56.
by notlob 9y ago
Your experience is standard practice for engineering senior design (sometimes called capstone).
57.
by notlob 9y ago
Perhaps so. It’s difficult to discuss anything adjacent to healthcare when it intersects with our lives in such a personal way. It’s really challenging to bridge the knowledge and experience gap as well. Insiders are the first to declare th
58.
by notlob 9y ago
I can't say I understand why you selected those two organizations: the CDC doesn't have pharma manufacturing expertise that I am aware of (interested to hear of what you know on that angle); the NSF is non-medical and it's a
59.
by notlob 9y ago
The clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketing surveillance activities (Phase IV) that are required. The alternate indicati
60.
by notlob 9y ago
The exclusivity period is intended to incentivize developing old drugs for new indications. What would you suggest instead of the exclusivity window?

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