Part11のゆくえ!?

当社のホームページでもお知らせしましたように、FDAが6/11に開催を予定していたPart11 Public Meetingが中止となりました。
中止の理由は、たてまえ上、故レーガン元大統領の国葬により政府機関が臨時休暇とされたためです。
しかしながら、再開催を予定していないことからもわかるように、実際には開催したとしても更に混乱を増すばかりであると推察できます。
Part11を改定し、本格的に実施したいFDAに対して、全面的にPart11廃止を要求する業界側とでは、全く意見が対立しています。
このままでは、公開討論を行っても収集がつかないのは明らかでしょう。
いったいFDAの意図はどこにあるのか、またPublic Meetingに何を求めて、どこにゴールをおいているのかがよくわかりません。
一方、”日本版Part11″である「医薬品等の承認又は許可に係る申請に関する電磁的記録・電子署名利用のための指針」は、本家のPart11がこんな状態ですから、なかなか出せないのが実情でしょう。
ところが、eCTDは来年4月から受付が開始されることになりましたから、その前提となる”日本版Part11″はそれまでに発行しなければなりません。
今後、日米両国における電子記録に関する規制要件がどの方向へ向かうのかは、混迷を極めるように思われます。

Related post

Comment

  1. behind the counter allergy medicine tablet for allergy on skin allergy pills non drowsy

  2. best sleep aid at walgreens buy modafinil sale

  3. generic deltasone 20mg order prednisone 20mg pills

  4. names of heartburn medication order retrovir 300mg pills

  5. acne treatments that work uk order benoquin generic treat acne

  6. allergy med comparison chart order astelin allegra side effects

  7. best 24 hour heartburn relief pepcid cheap

  8. oral isotretinoin 10mg buy generic isotretinoin 20mg brand isotretinoin 40mg

  9. amoxil over the counter oral amoxil 250mg buy amoxicillin 500mg sale

  10. best prescription sleep aids buy melatonin no prescription

  11. order generic zithromax 250mg how to buy zithromax cheap zithromax 500mg

  12. neurontin 600mg pill where to buy gabapentin without a prescription

  13. purchase azithromycin sale buy cheap azipro azipro price

  14. buy lasix 40mg for sale furosemide online

  15. buy omnacortil 40mg generic buy prednisolone tablets prednisolone 20mg pills

  16. buy amoxil cheap order amoxicillin 500mg generic buy amoxicillin 500mg sale

  17. vibra-tabs for sale online cheap doxycycline

  18. albuterol online buy albuterol 4mg online buy albuterol for sale

  19. augmentin 1000mg ca buy clavulanate generic

  20. synthroid over the counter levothyroxine pill purchase levoxyl for sale

  21. buy levitra for sale levitra 20mg price

  22. zanaflex price buy tizanidine generic buy tizanidine 2mg sale

  23. order clomid 100mg order serophene generic order clomiphene sale

  24. oral prednisone 10mg buy deltasone 5mg pill buy deltasone 20mg pill

  25. order semaglutide without prescription oral semaglutide 14 mg rybelsus sale

  26. buy accutane 10mg generic buy isotretinoin 20mg sale isotretinoin 40mg brand

  27. how to buy semaglutide order semaglutide semaglutide 14 mg usa

  28. order amoxicillin 500mg generic amoxicillin 1000mg usa order amoxicillin online cheap

  29. generic antihistamine pills ventolin 2mg inhaler cost albuterol inhalator

  30. azithromycin buy online order zithromax 250mg zithromax order

  31. how to buy augmentin amoxiclav medication buy clavulanate generic

  32. omnacortil 10mg oral omnacortil 10mg ca omnacortil 20mg brand

  33. buy synthroid 150mcg without prescription cheap levothyroxine online generic levothyroxine

  34. purchase gabapentin pill neurontin 100mg uk purchase neurontin sale

  35. buy serophene generic clomid 100mg for sale order clomiphene 50mg

  36. buy lasix 100mg for sale order lasix sale order furosemide 100mg generic

  37. cheap viagra generic sildenafil buy online sildenafil 100mg price

  38. purchase acticlate purchase monodox without prescription buy doxycycline 100mg pills

  39. order rybelsus 14 mg for sale rybelsus online order rybelsus 14mg pills

  40. casino slot games recommended you read casino game

  41. buy vardenafil for sale levitra online buy vardenafil uk

  42. buy pregabalin 75mg online cheap lyrica 150mg pills buy pregabalin 75mg online cheap

  43. hydroxychloroquine cost hydroxychloroquine without prescription order generic hydroxychloroquine

  44. generic aristocort 10mg aristocort price aristocort uk

  45. desloratadine ca buy clarinex 5mg sale order generic desloratadine

  46. cialis for daily use canadian cialis and healthcare generic tadalafil 40mg

  47. order loratadine 10mg generic loratadine 10mg generic loratadine where to buy

  48. buy cenforce 100mg online cheap order cenforce sale buy cenforce 100mg without prescription

  49. buy chloroquine 250mg pills buy chloroquine tablets cheap chloroquine 250mg

  50. buy priligy 30mg generic dapoxetine over the counter cytotec cheap

  51. orlistat without prescription orlistat over the counter order diltiazem online

  52. order metformin 500mg glucophage price cheap metformin 500mg

  53. buy zovirax allopurinol 300mg drug allopurinol price

  54. buy amlodipine generic norvasc cheap purchase amlodipine pill

  55. order crestor 10mg generic rosuvastatin 20mg for sale buy zetia without a prescription

  56. lisinopril 2.5mg tablet purchase zestril online buy zestril without a prescription

  57. buy motilium order sumycin 500mg online order tetracycline pills

  58. omeprazole 10mg without prescription omeprazole 10mg without prescription buy generic prilosec 20mg

  59. cyclobenzaprine 15mg sale oral cyclobenzaprine lioresal uk

  60. where to buy metoprolol without a prescription lopressor ca order lopressor 50mg online

  61. toradol pills gloperba without prescription colcrys generic

  62. tenormin 50mg for sale purchase atenolol online cheap buy tenormin online

  63. medrol brand name methylprednisolone 4 mg over the counter methylprednisolone 16mg over counter

  64. propranolol for sale propranolol brand purchase plavix pill

  65. essays done for you academicwriters my family essay writing

  66. methotrexate 2.5mg price order methotrexate online buy medex

  67. reglan for sale buy cheap generic hyzaar cost cozaar 25mg

  68. mobic 15mg usa purchase mobic online celebrex 100mg price

  69. cheap nexium 40mg purchase esomeprazole pill buy topamax 200mg pills

  70. buy flomax 0.4mg pills flomax 0.2mg cost buy celebrex 100mg without prescription

  71. sumatriptan 50mg generic levaquin 500mg brand levaquin 500mg drug

  72. order zofran 8mg sale spironolactone online order buy spironolactone no prescription

  73. brand avodart buy zantac 300mg online cheap buy zantac without a prescription

  74. oral simvastatin simvastatin online buy valacyclovir 1000mg oral

  75. finasteride 1mg generic purchase forcan pill diflucan 100mg pills

  76. ampicillin online order acillin us cheap amoxicillin generic

  77. buy baycip generic – ethambutol 1000mg price augmentin 375mg pill

  78. cipro 1000mg uk – cephalexin 125mg without prescription generic augmentin

  79. order generic ciplox – order amoxicillin 250mg for sale
    buy erythromycin 500mg online cheap

  80. order flagyl 200mg pill – azithromycin online order order zithromax pill

  81. ivermectine online – buy ceftin 500mg without prescription order sumycin without prescription

  82. valtrex 500mg usa – nemazole uk buy acyclovir 400mg online cheap

  83. brand ampicillin buy doxycycline cheap amoxicillin buy online

  84. how to get metronidazole without a prescription – buy zithromax medication order zithromax 500mg pills

  85. generic furosemide 100mg – buy minipress captopril sale

  86. order glycomet 1000mg generic – buy bactrim 480mg without prescription lincocin over the counter

  87. retrovir 300mg for sale – buy zyloprim 100mg without prescription

  88. order clozaril for sale – accupril 10mg for sale famotidine 40mg pills

  89. buy quetiapine without prescription – order desyrel 50mg for sale cheap eskalith pill

  90. buy anafranil 25mg generic – mirtazapine pills doxepin 75mg usa

  91. order hydroxyzine 25mg online cheap – cost hydroxyzine endep 25mg us

  92. amoxiclav without prescription – buy acillin for sale order ciprofloxacin 500mg generic

  93. buy generic amoxil – generic cefadroxil 500mg order cipro 500mg

  94. oral azithromycin – sumycin order online purchase ciplox online cheap

  95. I think what you published was actually very reasonable.
    However, think about this, suppose you were to create
    a awesome post title? I mean, I don’t wish to tell you how to run your website,
    but suppose you added something that grabbed a person’s attention? I mean Part11のゆくえ!?
    | お役立ち情報 is a little plain. You ought to peek at Yahoo’s home page and see how they create news headlines to grab viewers to open the links.
    You might add a related video or a related picture or
    two to grab people excited about what you’ve written. Just my opinion, it could
    make your posts a little bit more interesting.

  96. order cleocin generic – buy generic chloramphenicol buy chloramphenicol online

  97. where to buy stromectol – buy cheap aczone buy cefaclor 500mg for sale

  98. order albuterol 2mg sale – purchase seroflo without prescription theophylline pills

  99. medrol online pharmacy – cetirizine over the counter astelin cheap

  100. order clarinex 5mg generic – purchase ventolin pills albuterol cheap

  101. order micronase 5mg online cheap – micronase brand buy forxiga 10mg sale

  102. glycomet 500mg drug – order losartan online buy acarbose pills

  103. repaglinide 2mg generic – buy generic repaglinide 2mg purchase empagliflozin generic

  104. rybelsus cost – buy cheap generic glucovance buy generic desmopressin over the counter

  105. buy generic terbinafine – fulvicin 250 mg brand purchase griseofulvin generic

  106. ketoconazole ca – where can i buy ketoconazole sporanox order

  107. buy famvir without a prescription – order zovirax pill order valaciclovir sale

  108. order lanoxin generic – buy generic furosemide 100mg furosemide 40mg cost

  109. order metoprolol 50mg generic – order micardis 20mg generic purchase adalat pill

  110. hydrochlorothiazide 25mg pills – plendil 5mg ca buy bisoprolol for sale

  111. order nitroglycerin generic – buy combipres paypal valsartan drug

  112. zocor smoke – lopid eyebrow atorvastatin river

  113. crestor online widow – caduet online england caduet pills golden

  114. My coder is trying to convince me to move to .net from PHP.
    I have always disliked the idea because of the costs.
    But he’s tryiong none the less. I’ve been using WordPress on numerous websites for about a
    year and am concerned about switching to another platform.
    I have heard great things about blogengine.net.
    Is there a way I can import all my wordpress content into it?
    Any kind of help would be really appreciated!

  115. viagra professional online himself – malegra soar levitra oral jelly online beer

  116. priligy vast – suhagra station cialis with dapoxetine order

  117. cenforce online pony – brand viagra online tense

  118. brand cialis whip – brand cialis insist penisole speak

  119. brand cialis survive – brand levitra dwarf penisole indicate

  120. cialis soft tabs online doubt – caverta online life viagra oral jelly online fly

  121. cialis soft tabs right – cialis soft tabs pills prince viagra oral jelly barrel

  122. priligy pole – priligy sudden cialis with dapoxetine stiff

  123. cenforce mingle – brand viagra online animal brand viagra snake

  124. asthma treatment cup – asthma treatment solitary asthma medication uncle

  125. acne treatment skirt – acne medication steep acne treatment shoe

  126. prostatitis medications knife – prostatitis medications accord prostatitis medications field

  127. uti medication block – uti treatment mere uti treatment hit

  128. claritin pills beyond – claritin pills line claritin pills crack

  129. valacyclovir online add – valtrex pills descend valacyclovir online nor

  130. dapoxetine grip – priligy stretch priligy common

  131. loratadine medication attack – claritin man claritin roll

  132. ascorbic acid particular – ascorbic acid haul ascorbic acid vivid

  133. promethazine anyway – promethazine interview promethazine voice

  134. biaxin kill – ranitidine welcome cytotec pills recognize

  135. florinef urge – protonix value prevacid pills weigh

  136. order aciphex 20mg for sale – buy motilium generic domperidone buy online

  137. dulcolax over the counter – buy liv52 10mg without prescription liv52 usa

  138. zovirax usa – dydrogesterone 10 mg for sale dydrogesterone pills

  139. buy bactrim 960mg pills – where to buy keppra without a prescription tobrex 10mg tablet

  140. fulvicin 250 mg us – purchase fulvicin sale order lopid 300 mg generic

  141. buy cheap generic dapagliflozin – purchase precose buy acarbose 25mg without prescription

  142. dramamine online order – buy cheap dramamine order risedronate generic

  143. enalapril 5mg ca – buy zovirax for sale xalatan for sale

  144. buy etodolac 600mg generic – buy cilostazol cheap order pletal 100mg pills

  145. cost piroxicam 20 mg – buy exelon generic purchase rivastigmine sale

  146. cost nootropil 800 mg – order generic sustiva 10mg buy sinemet 10mg sale

  147. hydrea pill – antabuse 250mg price buy cheap methocarbamol

  148. divalproex 500mg uk – cheap aggrenox buy topamax 100mg generic

  149. purchase norpace without prescription – how to get norpace without a prescription thorazine us

  150. aldactone 25mg brand – buy dosulepin tablets cost revia 50 mg

  151. cyclophosphamide over the counter – cytoxan online buy vastarel generic

  152. buy flexeril generic – order primaquine online cheap enalapril 10mg cheap

  153. order ascorbic acid 500mg for sale – buy compro without a prescription purchase prochlorperazine for sale

  154. order durex gel for sale – buy durex gel online latanoprost cost

  155. purchase minoxidil generic – cheap dutas online how to get propecia without a prescription

  156. arava 10mg ca – order risedronate 35 mg online cheap cartidin buy online

  157. verapamil order online – buy diovan pills for sale buy tenoretic cheap

  158. atenolol buy online – tenormin for sale online buy carvedilol without a prescription

  159. order atorvastatin pill – buy enalapril without prescription nebivolol 5mg tablet

  160. purchase gasex online – buy generic gasex for sale buy generic diabecon

  161. lasuna brand – diarex usa buy himcolin generic

  162. cheap noroxin without prescription – oral eulexin confido without prescription

  163. buy finasteride pill – order sildenafil 100mg online alfuzosin uk

  164. order speman generic – buy finasteride paypal order finasteride sale

  165. order hytrin 5mg online cheap – hytrin brand order priligy 90mg sale

  166. trileptal 300mg sale – oxcarbazepine 600mg over the counter synthroid online order

  167. imusporin buy online – where to buy gloperba without a prescription buy colcrys without a prescription

  168. buy duphalac without prescription – where can i buy mentat order betahistine 16mg generic

  169. calcort online buy – alphagan for sale alphagan over the counter

  170. order besivance eye drops – purchase besifloxacin eye drops sildamax brand

  171. purchase neurontin for sale – azulfidine cost azulfidine cost

  172. purchase probalan – buy probenecid medication carbamazepine 200mg cost

  173. cheap celecoxib 100mg – buy celebrex 100mg online order indomethacin 50mg capsule

  174. colospa 135mg price – buy cilostazol 100mg online pletal 100 mg generic

  175. voltaren canada – aspirin buy online aspirin 75mg drug

  176. purchase rumalaya online – shallaki pills purchase endep for sale

  177. buy mestinon 60 mg without prescription – sumatriptan 25mg generic buy cheap generic azathioprine

  178. order baclofen 25mg without prescription – piroxicam 20 mg cheap feldene 20mg canada

  179. brand diclofenac – nimodipine canada nimodipine order online

  180. periactin 4mg over the counter – purchase tizanidine generic tizanidine oral

  181. buy mobic pills for sale – purchase toradol pill toradol 10mg cheap

  182. I got this web page from my buddy who informed
    me regarding this web page and now this time I am browsing this website
    and reading very informative posts here.

  183. buy cefdinir 300 mg without prescription – where can i buy clindamycin

  184. order trihexyphenidyl pill – diclofenac gel where to order buy voltaren gel

  185. It’s wonderful that you are getting ideas from this paragraph as
    well as from our discussion made at this time.

    Also visit my site … lottery defeated software reviews

  186. Do you have a spam issue on this site; I also am a blogger, and I was wondering
    your situation; we have developed some nice practices
    and we are looking to exchange solutions with other folks, be sure to shoot
    me an e-mail if interested.

    My web blog tonic greens side effects

  187. Nice blog here! Additionally your site so much up fast! What host are you the usage of?

    Can I am getting your associate hyperlink for your host?
    I wish my site loaded up as fast as yours lol

    Here is my page :: alphabites

  188. Hi, I wish for to subscribe for this webpage to take hottest updates, so where can i
    do it please assist.

    my web page gluco freedom pills

  189. I’m not sure exactly why but this weblog is loading very slow for me.
    Is anyone else having this issue or is it a issue on my end?

    I’ll check back later on and see if the problem still exists.

    Look into my blog post – alpha bites gummy

  190. I love it when individuals come together and share ideas.
    Great website, continue the good work!

    Feel free to surf to my blog :: iq blast pro

  191. What’s Happening i am new to this, I stumbled upon this I have
    discovered It absolutely helpful and it has aided me out loads.
    I am hoping to contribute & aid other users like its aided me.

    Great job.

    Feel free to visit my blog: the growth matrix sex

  192. When I initially commented I clicked the “Notify me when new comments are added” checkbox and now each time a comment is added I get
    several emails with the same comment. Is there any way you can remove people from
    that service? Thanks a lot!

    Here is my webpage tonic greens

  193. Everyone loves what you guys are up too. Such clever work and
    reporting! Keep up the excellent works guys I’ve added you guys
    to blogroll.

    Here is my page: amazon herpafend

  194. Hello, just wanted to mention, I liked this blog post.
    It was helpful. Keep on posting!

    Have a look at my blog post; what are the ingredients in prodentim

  195. Hi! I know this is kind of off topic but I was wondering if you knew where I could get a captcha plugin for my comment form?
    I’m using the same blog platform as yours and I’m having problems finding
    one? Thanks a lot!

    Feel free to surf to my web page – the growth matrix step-by-step youtube

  196. Hi! Someone in my Myspace group shared this website with us so I came
    to check it out. I’m definitely enjoying
    the information. I’m book-marking and will be tweeting this to my followers!
    Fantastic blog and terrific design.

    Check out my website; pronerve 6 reviews

  197. This site definitely has all of the info I needed concerning this subject and
    didn’t know who to ask.

    Look at my homepage; is prostalite a scam

  198. capecitabine oral – xeloda 500 mg cheap danocrine 100 mg sale

  199. Hey There. I found your blog using msn. This is a very well
    written article. I’ll make sure to bookmark it and return to read more of
    your useful information. Thanks for the post.

    I’ll certainly comeback.

    Also visit my website :: provadent .com

  200. progesterone 100mg usa – fertomid cheap cheap clomiphene pill

  201. alendronate price – provera cheap medroxyprogesterone 10mg drug

  202. Very shortly this web page will be famous amid all blogging
    people, due to it’s fastidious content

    My web site … lottery numbers

  203. buy generic norethindrone 5 mg – yasmin online buy yasmin order

  204. cost estrace 1mg – buy generic ginette 35 over the counter arimidex 1mg brand

  205. cabergoline 0.5mg generic – order premarin for sale alesse online order

  206. Neat blog! Is your theme custom made or did you download it from somewhere?
    A theme like yours with a few simple adjustements would
    really make my blog stand out. Please let me know where you got your
    theme. With thanks

  207. Hi there! I know this is kind of off topic but I
    was wondering which blog platform are you using for this site?
    I’m getting sick and tired of WordPress because I’ve had issues with hackers and I’m looking at
    alternatives for another platform. I would be great if
    you could point me in the direction of a good platform.

  208. гѓ—гѓ¬гѓ‰гѓ‹гѓі жµ·е¤–йЂљиІ© – 正規品アジスロマイシン錠の正しい処方 アジスロマイシン通販 安全

  209. バイアグラジェネリック йЂљиІ© – г‚·гѓ«гѓ‡гѓЉгѓ•г‚Јгѓ« йЈІгЃїж–№ г‚·г‚ўгѓЄг‚№йЂљиІ© 安全

  210. гѓ—гѓ¬гѓ‰гѓ‹гѓі её‚иІ© гЃЉгЃ™гЃ™г‚Ѓ – гѓ—гѓ¬гѓ‰гѓ‹гѓі йЈІгЃїж–№ アキュテイン гЃЇйЂљиІ©гЃ§гЃ®иіј

  211. Hi to every , since I am in fact keen of reading this blog’s post to be updated regularly.
    It consists of pleasant information.

  212. fantastic put up, very informative. I ponder why the opposite experts of this sector do not understand this.

    You should continue your writing. I am sure, you’ve a great
    readers’ base already!

  213. I’m very pleased to uncover this web site. I want to to thank you for ones
    time for this particularly fantastic read!! I definitely
    savored every part of it and I have you book marked to see new stuff
    in your blog.

  214. eriacta beam – sildigra group forzest quite

  215. valif pills frantic – order sinemet 10mg sinemet 20mg price

  216. where to buy indinavir without a prescription – buy generic confido diclofenac gel where to order

  217. valif online extra – secnidazole cost sinemet brand

  218. buy modafinil generic – how to buy lamivudine order lamivudine for sale

  219. promethazine us – promethazine brand lincocin cheap

  220. ivermectina online – ivermectin 12 mg otc tegretol 200mg brand

TOP