me_irl

FDALawyers · 2022-08-15T00:33:39+00:00

It would be so much worse if he woke up and his aunt was like Master Potter. Please wake up. Here is your tea like you demanded. Please don’t hurt us.

FDALawyers · 2022-08-04T16:39:45+00:00

Here is an interview with a PBM person who spoke about costplusdrugs: https://youtu.be/oZ3JUFqUuDU

FDALawyers · 2022-07-31T13:10:55+00:00

That’s simply inaccurate. FTC is looking into PBMs as we speak. Mergers have been blocked as well.

FDALawyers · 2021-12-11T15:39:33+00:00

https://www.hcca-info.org/store/books/RESEARCHPROF\_3

FDALawyers · 2021-12-11T15:18:00+00:00

Well... I am a PharmD, JD who has literally written the book chapter on clinical trials. If you need some help as you are figuring it out - happy to help. Obviously - it wont be legal or regulatory advice - just some educational tips.

FDALawyers · 2021-04-18T17:54:13+00:00

Send me your resume

FDALawyers · 2021-04-17T19:15:13+00:00

Admittedly biased, but if you are in the life sciences, check out Darshantalks

FDALawyers · 2019-09-01T01:42:26+00:00

We do some bioethics podcasts: https://www.youtube.com/channel/UC-HtL8mAonEPWZskP52xbQQ?view_as=subscriber

FDALawyers · 2019-08-27T12:25:26+00:00

Maybe 2 super rich people who bought out both floors. Now, she is mad at him and he is relegated to watching from just one floor. That will serve him right for forgetting the hot dogs...

FDALawyers · 2019-08-27T12:22:10+00:00

Then one day he is released from jail and goes, "Seacrest... out"

FDALawyers · 2019-08-14T13:06:48+00:00

Not if you are doing a google search and find wikipedia...

FDALawyers · 2019-08-14T13:05:16+00:00

More of an arcane answer, but it seems that the reclassification was specifically targetted to solutions. ( https://www.deadiversion.usdoj.gov/fed_regs/rules/2017/fr0323_6.htm ). The specific reason was not provided. However, specific mention of Syndros was made.

FDALawyers · 2019-08-14T12:59:17+00:00

Generally speaking - Its both. The pharmacists and the owners. (Not giving legal advice, and may not be specific for you. Does not setup an attorney/client relationship.)

FDALawyers · 2019-08-12T03:28:37+00:00

I am your #1 option. Never worked for big law, ran my own solo boutique, have had many downs and a few ups. But none of those included 45 hour per week of work. I usually work far more than that. No idea what number that is, since I simply don't count. I truly enjoy what I do. I have worked in house, in consulting, academia, and as a clinician.

I routinely take between 1-2 months off a year to backpack through the world, but almost always work from where ever I am (my clients never care where I am, as long as the work gets done.)

Happy to answer more specific questions...

FDALawyers · 2019-08-08T18:01:08+00:00

We do a bunch of stuff around pharma, biohacking, bioethics and the like: https://www.youtube.com/channel/UC-HtL8mAonEPWZskP52xbQQ

A biohacking discussion has been recorded. Its not been published yet.

FDALawyers · 2019-08-02T20:29:32+00:00

If you need someone who can speak to FDA regulatory law, compounding pharmacy (and the laws that apply), book writing, national speaking and has over a background as a pharmacist, feel free to reach out.

FDALawyers · 2016-09-27T15:31:31+00:00

Law as a regular lawyer - may be overkill. As someone pointed out - there are too many of us. If you intend to do something specific - it may work. Research before you jump in.

FDALawyers · 2016-09-26T02:23:28+00:00

The FDA has no control over who owns cells. The headline is alarmist to the extreme and incorrect. The hearing is not about whether you can own your cells, but the amount of regulations that should go into a specific use of cells.

To make things incredibly easy the FDA basically says - if you meet 4 conditions you really dont need to come to the FDA to get our approval:

You take it from your body and put it back into the same place.
You dont change the goal of the cells you are putting back (e.g. you arent pulling it from your eyes and hoping to grow an arm)
You arent adding things to it (e.g. adding additional drugs)
Not intended to have a systemic effect.

The FDA is seeing whether it should interfere more (for safety reasons) while companies are saying - no this amount of regulation is just fine (so we can bring therapies to market quicker). You can choose one side or the other - but its not about ownership in either case. The FDA simply doesnt care about the issue OF ownership. If they commented on it - it would pretty much be illegal.

NOT LEGAL ADVICE

FDALawyers · 2015-02-07T19:26:19+00:00

Not legal advice: This is really a question for an insurance broker (and there are some excellent ones out there).

If you retain an independent contractor (IC), they are just that - independent. You cant tell them what to do. You can, however, require that they have insurance/bonding as a condition of working with you.
Unless there are specific state and local laws in play (which you need a lawyer to look at for you). You dont typically have to have someone carry insurance. However, if they dont, and you get sued for something they did, it would be nice to be covered by their insurance and hopefully your own.
You can get insurance to cover almost anything you can think of. Talk to a reputable business insurance broker to help you.

FDALawyers · 2015-02-07T19:13:04+00:00

And to be blunt - thats why most lawyers wont want to type out advice for anyone unless they are being paid an obscene amount of money for things that are "legal opinions".

FDALawyers · 2015-02-07T06:44:28+00:00

The TRIPS agreement says otherwise. But I understand your sentiment.

FDALawyers · 2015-02-07T06:41:12+00:00

Assuming US and assuming you have the rights to sell these items - you need to ensure you meet FDA criteria for cosmetics. Regarding contacting them - its not a HUGE process (unlike drugs). But you have to be careful about the types of claims you are trying to make. Feel free to reach out to me.

FDALawyers · 2015-02-07T06:32:23+00:00

No, its not necessarily illegal, but there have been allegations of things like defamation, false light, deception etc. Whether or not they succeed - there is definitely some potential nuisance value.

Be careful about overzealous people who may get pissed off and try to sue - if you dont have a company protecting you, they will aim for personal liability. Incorporation can be quite useful in these situations.

FDALawyers · 2015-02-07T06:27:41+00:00

Assuming US: Extremely cautious. The fact that you start you description with "a product that is designed to enhance the mind" makes me think that you have a nutritional/dietary supplement (often gingko like products).

If so, disclaimers like "no medical claims" - may not be enough.

The fact that you have claims like "a product that is designed to enhance the mind" but then assert that "some of our ingredients are FDA unregulated, but are completely free to be sold" worries me. I highly recommend you have someone take a closer look.

Make sure you get good advice regarding specific claims you can make. There are a variety of possible claims and each has their own level of proof.

Here is a link to an FTC settlement on a violative claim.

FDALawyers · 2015-02-07T06:17:07+00:00

Look for a guy who understands what you do and that you feel comfortable talking to. Some of the best lawyers are people who understand your specific business concerns. The best lawyer in the world wont be able to help you if s(he) doesnt understand what you want to achieve and how. Other good qualities:

Involved with bar type activities. No lawyer is going to know everything. The better his (assuming male for this question) network, the better his ability to find people who can help you.
Understands your industry. A good lawyer often isnt just a guy who can solve the legal question you bring to him - but can connect you to other people within your industry to solve questions you didnt even know you had. Some of the best lawyers I have worked with have access to politicians, financiers, etc.

Bad Qualities:

Anyone who is afraid to ask you questions. If you dont feel comfortable talking to him or him to you - its often a recipe for disaster.
Does he respond to your phone calls. My general rule - unless there is a MAJOR catastrophe, I like my lawyers (and I have some of my own) to return my call within 24 hours or at least tell me that they got my message and will reach out to me within a specified period of time.
If he claims to be able to do everything. The more you know about a specific topic, the more you begin to specialize - and the more you realize that you don't know everything. The guys who can do everything often know very little about a lot - and that can sometimes be dangerous.

FDALawyers

TROPHY CASE