Skip To The Main Content

NEW FDA Guidance on COVID-19

by Regina Sester | Mar 18, 2020
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. F DA is committed to providing timely guidance to support continuity and response efforts to this pandemic. FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

For complete article click here: FDA Guidance on Conduct of Clinical Trials

173 comments

Leave a comment
  1. yusu | Aug 03, 2020
  2. yusu | Aug 03, 2020
    Great service, we must appreciate this things to go live.Buy TestogenTestosterone Booster GNCTestogen GNCTestogen for Sale
  3. mshahid | Aug 02, 2020
    The online market place is certainly bogged affordable utilizing phony personal blogs with out legitimate sales message however place was initially superb together with a good idea any look over. Thank you so much meant for posting the beside me.liteblue login
  4. Matthew Brick | Aug 01, 2020
    Place an order for Assignment Help in Singapore so you can connect with professional writers. Pay a good amount to buy the services of online assignment help even in Singapore.Online Assignment Help Assignment Help Online
  5. caralin | Aug 01, 2020
  6. boby | Aug 01, 2020
    I truly appreciate this article.Much thanks again. Great.Health Products | Men And Women Health Products | Health Product ReviewsBodyBuilding Result
  7. metilda | Aug 01, 2020
  8. mtom | Jul 30, 2020
    It’s difficult to find knowledgeable individuals about this topic, and you could be seen as do you know what you are talking about! Thanks n95 mask
  9. abdul bari | Jul 28, 2020
    the public schools on our district can really give some good education to young kids. they have high standards. mybkexperience
  10. Cupons Americanas | Jul 26, 2020
    Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include.Cupons Americanas
  11. mtom | Jul 25, 2020

    thank you for such a brilliant blog. Where else could someone get that kind of information written in such a perfect way? I have a presentation that I am presently working on, and I have been on the look out for such information. 먹튀

    ------------------------

    This post post made me think. I will write something about this on my blog.  m 토토사이트

  12. kids ride on cars | Jul 25, 2020
    I will do niche blog comment Just in 5$ .All comment relevant with your niche and UNIQUE .This off-page seo will increase your traffic and promote your business. kids ride on cars
  13. kids ride on toys | Jul 25, 2020
    I was reading your article and wondered if you had considered creating an ebook on this subject.  Your writing would sell it fast.  You have a lot of writing talent. kids ride on toys
  14. mshahid | Jul 24, 2020
    hello there and thank you for your info – I have certainly picked up something new from right here. I did however expertise several technical issues using this site, as I experienced to reload the web site lots of times previous to I could get it to load properly. I had been wondering if your web hosting is OK? Not that I’m complaining, but sluggish loading instances times will very frequently affect your placement in google and could damage your quality score if advertising and marketing with Adwords. Well I am adding this RSS to my e-mail and can look out for much more of your respective exciting content. Make sure you update this again soon. forvetbet mobil giriş
  15. Vanessa Duke | Jul 23, 2020
    http://riceback09.nation2.com/trim-tone http://robertresult2.jigsy.com/entries/general/Trim-Tone-Weight-Loss http://rosedrive9.nation2.com/tablets-trimtone http://rust.freelan.biz/index.php?subaction=userinfo&user=wishspider00 http://saltlead6.over-blog.com/2020/07/core-factors-of-trimtone-fat-burner-review-the-basics.html http://saskatoon.cs.rit.edu:10001/forcefowl69 http://savejury47.bravesites.com/entries/general/tablets-trimtone http://savesword92.iktogo.com/post/trim-tone-weight-loss-pills-reviews http://seguito.com/2020/07/19/a-background-in-painless-fat-burner-secrets/ http://selecthook8.bravesites.com/entries/general/what-pill-can-i-take-to-lose-belly-fat http://signpaint1.bravesites.com/entries/general/trim-tone-weight-loss-pills-reviews http://sindicatodechoferespichincha.com.ec/index.php?option=com_k2&view=itemlist&task=user&id=7320805 http://soundbeast33.diowebhost.com/28176715/tablets-trimtone http://spacehoe8.iktogo.com/post/trim-tone http://stagescore.com/locating-effective-solutions-of-fat-burner/ http://stageshrimp43.nation2.com/what-pill-can-i-take-to-lose-belly-fat http://stageskate39.iktogo.com/post/trimtone http://steampump36.jigsy.com/entries/general/Trim-Tone-Weight-Loss http://suedeyear28.diowebhost.com/28176690/what-pill-can-i-take-to-lose-belly-fat http://teatw666.com/home.php?mod=space&uid=30092 http://tenortip7.xtgem.com/__xt_blog/__xtblog_entry/__xtblog_entry/16606994-finding-uncomplicated-programs-in-trimtone-fat-burner-review?__xtblog_block_id=1#xt_blog http://thickpaper.com/2020/07/19/no-fuss-secrets-of-trimtone-reviews-where-to-go/ http://thumbbeach13.bravesites.com/entries/general/trim-tone-weight-loss-pills-reviews http://thumbdollar24.jigsy.com/entries/general/TrimTone http://topfreepicks.com/2020/07/19/real-world-fat-burner-methods-updated/ http://trucktaurus13.nation2.com/trim-tone-weight-loss http://tuansogarmanurung.org/index.php?option=com_k2&view=itemlist&task=user&id=672646 http://unionisstrength.com/index.php?qa=user&qa_1=pandafir70 http://vestvault6.over-blog.com/2020/07/effective-best-fat-burner-for-women-advice-some-thoughts.html http://walrusyarn0.diowebhost.com/28176689/what-pill-can-i-take-to-lose-belly-fat http://web.jmjh.tn.edu.tw/~env/modules/profile/userinfo.php?uid=1558223 http://web.sfusd.edu/Services/research_public/Lists/Sample%20Copy/DispForm.aspx?ID=228773 http://whalesalt38.diowebhost.com/28176684/trim-tone-weight-loss-pills-reviews http://wiki.soippo.edu.ua/index.php?title=Realistic-trimtone-reviews-Products-Considered-f http://worldhighlight.com/a-guide-to-trouble-free-methods-in-trimtone-reviews/ http://woundjudo7.nation2.com/trim-tone-weight-loss http://woundtaste0.bravesites.com/entries/general/trim-tone http://wristfork28.iktogo.com/post/what-pill-can-i-take-to-lose-belly-fat http://www.0510365.com/home.php?mod=space&uid=1559964 http://www.0798wang.com/home.php?mod=space&uid=170815 http://www.4kquan.com/space-uid-538361.html http://www.98youx.com/space-uid-66620.html http://www.ajie.cn/space-uid-207275.html http://www.autogm.it/index.php?option=com_k2&view=itemlist&task=user&id=2128547 http://www.avanzaxenia.org/member.php?action=profile&uid=279426 http://www.bsaa.edu.ru/bitrix/rk.php?goto=https://sfdh.org/trimtone/ http://www.ccwin.cn/space-uid-3788005.html http://www.chimisal.it/index.php?option=com_k2&view=itemlist&task=user&id=1286269 http://www.chuanqidianshang.com/home.php?mod=space&uid=586247 http://www.dellemimose.it/index.php?option=com_k2&view=itemlist&task=user&id=528851 http://www.eduplan.cl/l/index.php/component/users//index.php?option=com_k2&view=itemlist&task=user&id=185497 http://www.erasmusworld.com/portal/userinfo.php?uid=549021 http://www.ergoplus.it/index.php?option=com_k2&view=itemlist&task=user&id=4152290 http://www.feedbooks.com/user/6338433/profile http://www.fndtech.com/bbs/home.php?mod=space&uid=691496 http://www.gefq.cn/home.php?mod=space&uid=1925381 http://www.gu98.cn/space-uid-245762.html http://www.hydrocarbs-gh.org/index.php?option=com_k2&view=itemlist&task=user&id=9386579
  16. john | Jul 22, 2020
    Fat Burn X Awesome! Its in fact amazing article,K2 Slim Keto Diet Reviews
    truly appreciate this blog post.Much thanks again. Really Great. Trim 14 Reviews
      
  17. mike | Jul 22, 2020
    muscle gains By CrazyBulkGreat blog here! Also your website loads up fast!best alternative steroidsGreat blog here! Also your website loads up fast!dianabol legal alternativeGreat info! I recently came across your blog and have been reading along
  18. mika | Jul 22, 2020
    Best penomet PumpGreat blog here! Also your website loads up fast!naturalproductsGreat info! I recently came across your blog and have been reading alongbest male enhancement pills For Bigger and boost libido
  19. Mark | Jul 22, 2020
    great service, we must appreciate this things to go live

    American Diet Pills,PhenQ Australia, PhenQ Belgium, PhenQ Canada, Phenq Deutchland, PhenQ Denmark, PhenQ FrancePhenQ Italia, PhenQ Netherlandsphenq Spain And PhenQ Sverige

    https://maxxau.com  https://maxxcanada.com
  20. tm | Jul 22, 2020

    Fantastic blog! Do you have any suggestions for aspiring writers? I’m hoping to start my own blog soon but I’m a little lost on everything. Would you suggest starting with a free platform like Wordpress or go for a paid option? There are so many choices out there that I’m totally overwhelmed .. Any ideas? Appreciate it! 바카라사이트

    ====

    Hey, just looking around some blogs, seems a pretty nice platform you are using. I’m currently using WordPress for a few of my sites but looking to change one of them over to a platform similar to yours as a trial run. Anything in particular you would recommend about it? 토토사이트

  21. mtom | Jul 22, 2020

    I am thankful that I detected this site, just the right info that I was looking for! UFABET

    --------------------------

    I just now wanted to inform you about how much I appreciate every thing you’ve contributed to help increase the value of the lives of people in this theme. Listrik Tenaga Surya

  22. Miten tunnistan luotettavat kasinot | Jul 21, 2020
    Hey There. I found your blog using msn. This is a very well written article. I’ll be sure to bookmark it and come back to read more of your useful info. Thanks for the post. I’ll definitely return. Miten tunnistan luotettavat kasinot
  23. getyrl,ogt | Jul 21, 2020

    I like the helpful information you provide in your articles. I’ll bookmark your weblog and check again here regularly. I’m quite certain I will learn lots of new stuff right here! Best of luck for the next! 라이브스코어중계

    ===

    We still cannot quite believe that I should often be a kind of checking important points seen on your webblog. Our family and i also are sincerely thankful with regards to your generosity too as for giving me possibility pursue our chosen profession path. Wanted you important information I purchased within your web-site. 먹튀검증

  24. mshahid | Jul 21, 2020
    certainly like your web-site but you have to check the spelling on quite a few of your posts. Many of them are rife with spelling problems and I in finding it very bothersome to inform the truth however I will definitely come again again. KKTC bahis siteleri
  25. lisa123 | Jul 20, 2020
    Thanks for sahare this information if you are looking blockchain related service thenx click here:
    Blockchain Technical Support USA
    Blockchain Wallet Service USA
  26. jiva | Jul 20, 2020
     HCG complex diet Drops I will visit your blog regularly for some latest post and This is a great article thanks for sharing this informative informationinformative post  supplementguidesg.net
  27. Connect to brother wireless printer windows 10 | Jul 20, 2020
    I really appreciate the kind of topics you post here. Thanks for sharing  information that is actually helpful. Good day!  Connect to brother wireless printer windows 10
  28. ty | Jul 19, 2020
    Excellent blog right here! Additionally your site loads up fast! What web host are you using? Can I get your associate link in your host? I desire my site loaded up as quickly as yours lol 토토사이트
  29. desifood | Jul 19, 2020
    The work I am doing is very hard but articles like this make it much easier. Thank you for doing my research for me. desifood
  30. Ly The Dung | Jul 18, 2020
    I really appreciate this wonderful post that you have provided for us. I assure this would be beneficial for most of the people.Ly The Dung
  31. lythedung | Jul 18, 2020
    I really loved reading your blog. It was very well authored and easy to undertand. Unlike additional blogs I have read which are really not tht good. I also found your posts very interesting. In fact after reading, I had to go show it to my friend and he ejoyed it as well!lythedung
  32. mshahid | Jul 17, 2020
    Its amazing what supplementing  can do for your body and your weight lifting goals. best10
  33. Process service | Jul 16, 2020
    Thank you for giving away this wonderfull post! Process service
  34. mtom | Jul 16, 2020

    Thank you for the good writeup. It in fact was a amusement account it. Look advanced to more added agreeable from you! By the way, how could we communicate? mesin digital printing

    -*------------------

    This is great content.  You’ve loaded this with useful, informative content that any reader can understand.  I enjoy reading articles that are so very well-written. jasa fotografi

  35. mshahid | Jul 15, 2020
    I was curious if you ever considered changing the page layout of your blog? Its very well written; I love what youve got to say. But maybe you could a little more in the way of content so people could connect with it better. Youve got an awful lot of text for only having one or two pictures. Maybe you could space it out better. best10
  36. mtom | Jul 15, 2020
    leather jackets can really make you look good, they also make you feel warm and comfortable;; balayage hair color lilydale
  37. harry | Jul 15, 2020
    This is highly informatics, crisp and clear. I think that everything has been described in systematic manner so that reader could get maximum information and learn many things.   download facebook videos
  38. mtom | Jul 15, 2020
    After study some of the blog articles in your web site now, and I truly appreciate your way of blogging. I bookmarked it to my bookmark website list and will also be checking back soon. Pls consider my web site too and tell me what you believe. balayage hair color lilydale
  39. John Mathew | Jul 14, 2020
    I was surprised to know that there are such talented professionals online. Earlier I was against these academic assistance services, but now I understand their importance and how they actually help the students learn from the experts. These assignments are also a great alternative to monotonous study materials provided by the professors. These write-ups allow the students to gain new perspectives. CPA Program Assignment Help
  40. Dell Error Code 2000-0122 | Jul 14, 2020

    I would like to thank you for the efforts you have made in writing this article. I am hoping the same best work from you in the future as well. In fact your creative writing abilities has inspired me.

    Dell Error Code 2000-0122

  41. mtom | Jul 13, 2020

    You need to join in a contest for just one of the greatest blogs online. I am going to suggest this page! 검증사이트

    ----------------------------------------

    An impressive share, I recently given this onto a colleague who had previously been conducting a little analysis during this. Anf the husband in truth bought me breakfast since I found it for him.. smile. So well then, i’ll reword that: Thnx for that treat! But yeah Thnkx for spending some time to debate this, I feel strongly regarding this and love reading regarding this topic. If you can, as you grow expertise, could you mind updating your blog post to comprehend details? It can be highly useful for me. Big thumb up due to this text! 토토사이트

  42. amara smith | Jul 13, 2020
    Online assignment help connects students with professional assignment writers even in the UK. So, place your order for excellent online assignment writing services with trustworthy service providers like us.
  43. mtom | Jul 12, 2020

    very good post, i certainly love this website, keep on it 먹튀사이트 검증



    -----------------------------

    The next time I learn a weblog, I hope that it doesnt disappoint me as much as this one. I imply, I do know it was my choice to learn, but I truly thought youd have one thing interesting to say. All I hear is a bunch of whining about one thing that you would repair in the event you werent too busy on the lookout for attention. 먹튀

  44. mtom | Jul 12, 2020

    the best air purifiers are usually the ones using hepa filters but they are very very expensive, https://baduki2020.com

    --------------------

    Great  post, you have pointed out some  fantastic   details , I  too   believe  this s a very  excellent  website. https://www.caz79.com

  45. mtom | Jul 12, 2020

    Some genuinely wonderful articles on this website, regards for contribution. 먹튀검증

    ------------

    I love your blog.. very nice colors & theme. Did you create this website yourself or did you hire someone to do it for you? Plz answer back as I’m looking to create my own blog and would like to know where u got this from. thanks 조건만남

  46. mtom | Jul 12, 2020

    Hello! I recently would want to supply a large thumbs up to the great information you could have here within this post. We are returning to your website for more soon. https://baduki2020.com

    ----------------

    There are certainly a lot of details that adheres to that to think about. Which is a excellent specify raise up. I offer the thoughts above as general inspiration but clearly there are actually questions like the one you start up where most critical thing will be in honest very good faith. I don?t know if best practices have emerged around such thinggs as that, but Almost certainly that the job is clearly defined as a reasonable game. Both children have the impact of merely a moment’s pleasure, through out their lives. https://www.caz79.com

  47. lisa | Jul 12, 2020
    hello this  is very good blog i am read it. if you are looking blockchain service then click here
    Blockchain Wallet Support
    Blockchain Customer Service
  48. mtom | Jul 11, 2020

    Do you have a spam issue on this website; I also am a blogger, and I was wanting to know your situation; we have created some nice practices and we are looking to trade methods with others, please shoot me an email if interested. Bluetooth accessories Kenya



    ----------------

    Wow, you seem to be very knowledgable about this kind of topics.`–’, MacBook No Display fix in Nairobi /near me

  49. mtom | Jul 11, 2020

    Pourquoi ne pas rapporter les valeurs annoncées les journées passées par l’état national? Au moins on aurait la possibilité de chicaner selon les vrais chiffres. headphones price in Kenya

    -----------------

    You seem to be very professional in the way you write.;*”- MacBook Memory / Ram Upgrade in Nairobi /near me

  50. john | Jul 11, 2020
    Valuable post Norton Promo Codes content. You have given outstanding information about sites.I am searching forward for your next accommodating substance. 

    Leave a comment