Tag Archive: IND

Mar 16

Jump on the Development Safety Update Report (DSUR) Bandwagon!

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic reporting requirements. Many US-based sponsors have opted for the Annual Report format when it comes to their IND (sections 1.13.1 to 1.13.14 of the IND; …

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Aug 04

New FDA Guidances for July 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in July 2015, are posted.  In addition, upcoming advisory committee meetings to be held in September are also listed below with a link to more information. Special Interest Guidances/Information Date Posted Dissolution Testing and Specification …

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Jun 01

New FDA Guidances for May 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in May, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information. Also, as we strive to keep you updated on …

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May 11

New FDA Guidances for April 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in April 2015, are posted.  In addition, upcoming advisory committee meetings to be held in the next couple months are listed below with links to more information.  Special Interest Guidances/Information Date Posted Biosimilars: …

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Apr 13

New FDA Guidances for March 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in March 2015, are posted.  Two updates to the CDER Manual of Policies and Procedures (MAPP) are included.  In addition, upcoming advisory committee meetings to be held in the next couple months are …

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Mar 02

New FDA Guidances for February 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February 2015, are posted.  Two updates to the CDER Manual of Policies and Procedures (MAPP) are included.  In addition, upcoming advisory committee meetings to be held in the next couple months are …

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Feb 19

Authoring for eCTD – Know the Requirements and Think Like a Reviewer

By Jessica Long, B.S., R.A.C., Regulatory Associate II/Submissions Specialist at Cato Research “Before you judge a man, walk a mile in his shoes.”  ― Cherokee Proverb Judgment has nothing to do with this post; seeing things through a different perspective has everything to do with it. There are many guidances on the content of granular electronic …

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Oct 31

New FDA Guidances for October 2014 & Critical Path Innovation Meetings

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in October are posted. In addition, upcoming Advisory committee meetings are listed below with links to more information on each. Of interest this month is a draft guidance on a new type of meeting …

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Oct 03

New FDA Guidances for September 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in September, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information. Special Interest Guidances/Information Date Posted ANDA Submissions — Refuse-to-Receive …

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Oct 10

New FDA Guidances for September 2013

September was a big month for CDRH Guidances.  Both the final Mobile Medical Applications Guidance and the much awaited Guidance on the Unique Device Identification Database were released.  More information about the Unique Device Identifier program can be found here. Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration Generic Drug User Fee Amendments …

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