[1] eCFR :: 21 CFR 312.32 -- IND safety reporting https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-B/section-312.32 [2] eCFR :: 21 CFR 312.33 -- Annual reports https://tools.pdf24.org/zh/edit-pdf#s=1714030331113 [3] Safety ReportingRequirements ...
[2] eCFR :: 21 CFR 312.33 -- Annual reports ecfr.gov/current/title- [3] Safety ReportingRequirements for INDs and BA/BE Studies fda.gov/media/79394/dow [4] E2F Development Safety Update Reportfda.gov/media/71255/dow [5] Federal Register :: Investigational New Drug Application Annual Repor...
Alltrista of Muncie, Ind., Reports Rise in Annual Earnings.(Originated from The Indianapolis Star and News)Koenig, Bill
SOUTH SAN FRANCISCO, Calif., Jan. 31, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has cleared ...
As key opinion leaders, Certara’s submission leads speak regularly at major industry events such as DIA Annual and AMWA’s Medical Writing and Communication Conference. Contact us Regulatory writing to expedite your submissions When it comes to regulatory writing and medical writing, our team of hi...
A monetary fine is being applied to the reporting entity. Reports to be Submitted under the FIU-India Under the PMLA and respective rules, different forms of reports must be submitted by the reporting entities. The following are the types of reports which have to be submitted under FIU-India...
Puma Biotechnology, Inc. has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug Application (IND) submission has been reviewed, and Puma can proceed with the clinical development of al...
On an annual basis, the company will provide the following information to the Registrar when it files a financial statement: The name of the service provider The Internet Protocol (IP) address of the service provider The location of the service provider, wherever applicable ...
The supported integration option is available for companies that can access IRP through direct application programming interface (API) access. Currently, this access is granted only to companies that have annual turnover that exceeds the defined threshold, or that have registered in the e-Way Bill ...
Messrs. Murthy, Pai and Batni will hold office up to the date of the next Annual General Meeting, when their appointment as whole-time directors will be placed for the approval of the members in general meeting. Mr. Susim M. Dutta retired as a director of the company on May 27, 2000...