By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in February and March are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Chronic Obstructive Pulmonary Disease: Use of the St. …
Category Archive: Regulatory Affairs
Mar 27
Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?
By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate at Cato Research Submitting IND safety reports to an IND in eCTD format is slightly different when using us-regional DTD v3.3 versus v2.01. Keep in mind that the following aspects remain UNCHANGED for both versions: Each individual IND safety report should be provided in Section 5.3 of …
Mar 08
Deadline to Begin Submitting Commercial INDs in eCTD Format is May 5, 2018
By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the electronic common technical document (eCTD) format. Section 745A(a) of the Food, Drug, and Cosmetic Act (FD&C Act) authorizes the United States Food and Drug Administration (FDA) to …
Mar 01
Submitting a “Request for Proprietary Name Review” in eCTD format to the FDA
By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate at Cato Research Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission for the Evaluation of Proprietary Names”, applicants must submit proposed proprietary names to the FDA for review as part of New Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics License Applications (BLAs). …
Feb 20
New FDA Guidances for January 2018
By Sheila Plant, PhD, MHS, RAC (US), Assistant Director, Regulatory Strategy, US, Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in January 2018 are posted. CDRH has also released an “A-list” and a “B-list” of proposed guidances for fiscal year 2018 and is seeking feedback on the relative priority …
Feb 15
What’s New Health Canada?
By Sandra Salem, Ph.D., Regulatory Scientist What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Health Canada New Guidance Documents (Drugs, Biologics, Medical Devices and Natural & Non-prescription Health Products) Health Canada Guidance Type …
Jan 22
Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products
By: Robert McNeill, Ph.D., Scientist at Cato Research In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for industry titled Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products (Version date: 18 December 2017) (2017 PDUFA Meetings draft guidance). At the same time, two guidance documents were …
Jan 17
South Africa is Transitioning to a New Regulator of Medicines and Medical Devices
By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World Cato Research, South Africa On 01 June 2017, the President of South Africa proclaimed revisions to the Medicines Act. These provide for the creation of a new regulatory authority, known as the South African Health Products Regulatory Authority (SAHPRA). This new …
Jan 05
New FDA Guidances for December 2017
By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in December 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Labeling for Combined Hormonal Contraceptives – Draft Guidance …
Dec 22
What’s New Health Canada?
By Amelie Rodrigue-Way, PhD, RAC (CAN), Associate Director, Regulatory Strategy What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Health Canada New Guidance Documents (Drugs and Biologics) Health Canada Guidance Type Date Posted Quality (Chemistry and Manufacturing): New Drug …
