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Regulatory One

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Regulatory One: GDUFA AND ITS CONSEQUENCES

Thanks a lot for your feed back, Manikanta. Appreciate it!
http://www.regulatoryone.com/2013/03/gdufa-and-its-consequences.html - Details - Similar

Disposal of Unused Medicines: What You Should Know | FDA

Learn how to dispose of unused or expired drugs
https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know - Details - Similar

Regulatory One: Webinars by FDA Personnel

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Electronic Common Technical Document (eCTD) | FDA

Electronic Common Technical Document (eCTD) mandatory use for some submissions starts May 2017. eCTD is the standard format for electronic reg submissions.
https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd - Details - Similar

MedWatch: The FDA Safety Information and Adverse Event Reporting Progr

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program - Details - Similar

Regulatory One: eCTD Issues for ANDA Submissions

Its very nice to see you blogging, after a very long gap. Welcome back dear friend Rajesh..... We are expecting much more from you your blog. Waiting for more and more articles of similar standards.By Donpharmatreasure
http://www.regulatoryone.com/2016/01/ectd-issues-for-anda-submissions.html - Details - Similar

DAYTRANA (methylphenidate) | ADHD medication

Discover DAYTRANA®, the once-daily ADHD medicated patch. Read the full Prescribing Information, including Boxed Warning regarding abuse and dependence.
http://www.daytrana.com/ - Details - Similar

EFFEXOR XR® (venlafaxine HCl) Homepage | Safety Info

Click to learn about EFFEXOR XR® (venlafaxine HCl). Please see the Med Guide & Full Prescribing Info, including Boxed WARNING.
https://www.effexorxr.com/ - Details - Similar

Medical device - Wikipedia

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended pur
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