drgunasakaran1
★★  
avatar

2014-11-03 18:18
(4250 d 17:37 ago)

Posting: # 13827
Views: 4,046
 

 FDA released guidance on Circumstances that Constitute Delay [Regulatives / Guidelines]

Dear all,

FDA released Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2014-11-09 13:37
(4244 d 22:18 ago)

@ drgunasakaran1
Posting: # 13846
Views: 2,843
 

 Refusing an inspection…

Dear Dr. Gunasakaran,

thanks for posting. Seems to be necessary: Beijing Shunxin Meihua Bio-technical Co., Ltd. 9/29/14

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
112 visitors (0 registered, 112 guests [including 16 identified bots]).
Forum time: 12:55 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5