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 Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs – Draft Guidance 31 Jul 2015
Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation – Final Guidance 31 Jul 2015
Request for Quality Metrics Guidance for Industry – Draft Guidance 27 Jul 2015
Analytical Procedures and Methods Validation for Drugs and Biologics – Draft Guidance 24 Jul 2015
Gastroparesis: Clinical Evaluation of Drugs for Treatment – Draft Guidance 22 Jul 2015
Testicular Toxicity: Evaluation During Drug Development – Draft Guidance 16 Jul 2015
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices – Draft Guidance 14 Jul 2015
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing – Draft Guidance 09 Jul 2015
Qualification of Biomarker–Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease – Draft Guidance 02 Jul 2015
Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements – Final Guidance 01 Jul 2015
Upcoming Meetings (* = New)
* Vaccines and Related Biological Products Advisory Committee Meeting, 15 September 2015; Silver Spring, MD
* Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, 24 September 2015; Silver Spring, MD

* new entry

Last updated: 03 August 2015

Posted in Cato Research, Drug Development, FDA, Regulatory Strategy, Regulatory Submissions | Tagged , , , , , , | Comments Off on New FDA Guidances for July 2015

Using a Clinical Trial Management System (CTMS) to Streamline Investigator Payments

by Sonya Cato, MS, Cato Research CTMS Administrator

A key feature of Cato Research’s clinical trial management service is the administration of investigator payments. Multicenter clinical trials provide unique challenges in this area that can be managed through the use of an efficient, integrated CTMS.

During the preparation for the conduct of a clinical trial, significant time and effort are invested in the development and negotiation of clinical trial agreements with each clinical site participating in the study. Each agreement includes a customized, detailed site budget that itemizes the activities for which the site will be compensated for its implementation of the study protocol. Site budgets frequently include compensation for start-up activities, subject visits, specialized subject procedures, screen-failed subjects, and special equipment costs. It is a normal practice for clinical sites to be compensated for a subject visit only after the data for that visit have been monitored by a clinical research associate. In addition to the site budget, the clinical trial agreement specifies the frequency in which payments will be made to the clinical site.

Cato Research uses BioClinica’s CTMS as a tool for managing site payments.   Within the payments module, Cato Research can design payment programs for clinical sites and calculate the actual payment due based on negotiated contracts and verifiable clinical activity. Site payment milestones are tracked as they occur, a process that queues them for inclusion in the next invoice generated. Subject, procedure, and monitoring data are uploaded automatically to the CTMS through integration with the electronic data capture system, allowing queuing of payments for subject-related information to occur with minimal data entry by project management.

The CTMS allows invoices to be generated independently for each clinical site according to the contracted payment schedule. Draft invoices generated from the CTMS are reviewed internally and modified as necessary to accurately reflect the activities for which the site can be reimbursed. An important feature of the CTMS is its ability to defer the full or partial payment of an invoice item to a later invoice. For example, if a subject visit has occurred and been monitored, but the electronic case report form for that visit has numerous outstanding edit checks, the project manager may choose to defer payment for that visit until the issues have been resolved. After the invoice has been approved, the CTMS generates an invoice that contains all the information needed to issue the payment. Once paid, the invoice is logged as completed in the CTMS, along with relevant payment details.

Using the CTMS, project management can track payments made to date against total study budget at study, site, and subject levels and generate payments for investigators based on the contract details for payment. The process aligned with the CTMS provides study managers and project stakeholders with real time data that enables accurate and timely payments to the investigators.

Posted in Clinical Trials, CTMS, Drug Development | Tagged , , | Comments Off on Using a Clinical Trial Management System (CTMS) to Streamline Investigator Payments

New FDA Guidances for June 2015

By Brant Hamel, Ph.D. and Sheila Plant, Ph.D., R.A.C., Regulatory Scientists at Cato Research
FDA draft and final guidances, released from CDER, CBER, and CDRH in June 2015, are posted.  In addition, a single upcoming advisory committee meeting to be held in July is also listed below with a link to more information.

Special Interest Guidances/Information Date Posted
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings – Draft Guidance 30 Jun 2015
DSCSA Implementation: Product Tracing Requirements for Dispensers – Final Guidance 30 Jun 2015
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance 29 Jun 2015
Unique Device Identification: Direct Marking of Devices – Draft Guidance 26 Jun 2015
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products– Final Guidance 24 Jun 2015
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules– Final Guidance 18 Jun 2015
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions– Draft Guidance 18 Jun 2015
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices – Final Guidance 17 Jun 2015
Naming of Drug Products Containing Salt Drug Substances – Final Guidance 16 Jun 2015
Assessment of Male- Mediated Developmental Risk for Pharmaceuticals Guidance for Industry – Draft Guidance 11 Jun 2015
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) – Final Guidance 10 Jun 2015
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 9 Jun 2015
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products – Final Guidance 9 Jun 2015
Upcoming Meetings (* = New)
* Oncologic Drugs Advisory Committee Meeting, 09 July 2015; Silver Spring, MD

* new entry
Last updated: 01 July 2015

Posted in Cato Research, Clinical Trials, Drug Development, eCTD, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , , , , , , | Comments Off on New FDA Guidances for June 2015

Credentialing Developments at Cato Research

In 2014, approximately 20-25 members of the global CATO staff participated in extensive training sessions devoted to Canadian Regulatory Affairs. This effort was led by Amelie Rodrigue-Way, PhD from the Montreal office of CATO Research Ltd.

During the last 8 months, one of the tangible and visible results of this training has been the successful completion of the Canadian Regulatory Affairs Certification Examination by two members of the global Cato Research staff:  Dr. Amelie Rodrigue-Way (of CATO’s Montreal office) and Dr. Jack Snyder (of CATO’s Washington office).

Fewer than 500 individuals worldwide have achieved the designation of Certified in Canadian Regulatory Affairs, a credential sponsored by the Regulatory Affairs Professional Society (Rockville, MD).

This achievement speaks to the continuing effort at CATO to acquire and maintain up-to-date regulatory knowledge, experience, and credentials relevant to global biomedical product developmental activities.

Posted in Canadian Regulatory Affairs, FDA, Regulatory Strategy, Regulatory Submissions | Tagged , , , | Comments Off on Credentialing Developments at Cato Research

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 the latest FDA guidances, please note that FDA has officially withdrawn 47 draft guidances.  All guidances were published prior to 31 December 2013 but were never finalized.  The full list of withdrawn guidances, published in the Federal Register on 06 May 2015, can be found here:  http://www.gpo.gov/fdsys/pkg/FR-2015-05-06/html/2015-10477.htm.

Special Interest Guidances/Information Date Posted
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry – Draft Guidance 29 May 2015
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk – Final Guidance 27 May 2015
Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures – Final Guidance 27 May 2015
ANDA Submissions — Refuse-to-Receive Standards – Final Guidance 26 May 2015
Adaptive Designs for Medical Device Clinical Studies – Draft Guidance 18 May 2015
Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling– Draft Guidance 18 May 2015
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators– Draft Guidance 14 May 2015
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment – Draft Guidance 12 May 2015
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 – Draft Guidance 12 May 2015
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products – Draft Guidance 12 May 2015
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices – Draft Guidance 06 May 2015
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – Revision 3; Draft Guidance 05 May 2015
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System – Revision 1, Draft Guidance 05 May 2015
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States – Draft Guidance 22 Apr 2015
Upcoming Meetings (* = New)
Transmissible Spongiform Encephalopathies Advisory Committee Meeting; 01 June 2015; Silver Spring, MD
* Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting; 04 June 2015; Silver Spring, MD
* Risk Communication Advisory Committee Meeting; 08-09 June 2015; Silver Spring, MD
Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 09 June 2015; Gaithersburg, MD
Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 10 June 2015; Gaithersburg, MD
* June 11, 2015: Pulmonary-Allergy Drugs Advisory Committee Meeting; 11 June 2015; Gaithersburg, MD

* new entry

Last updated: 01 June 2015

Posted in Cato Research, Clinical Trials, Drug Development, FDA | Tagged , , , , , , , | Comments Off on New FDA Guidances for May 2015