Monday, August 8
1:00 PM - 2:00 PM EST
Webinar Details: HERE
The FDA published a final
guidance, describing the regulatory framework for extrapolating existing
data to evaluate a device’s performance in pediatric patients in pre-market
approval applications (PMAs), humanitarian device exemptions (HDEs) and de
novo requests.
This guidance:
- explains the conditions
in which FDA believes it may be appropriate to leverage existing clinical
data to support pediatric device indications and labeling;
- outlines the approach
FDA uses to determine whether extrapolation is appropriate and to what
extent; and
- describes statistical
methodology that can be used to leverage data for pediatric implications.
FDA will discuss this final guidance document at a webinar
scheduled for August 8, 2016. The webinar is intended to help
manufacturers and other interested stakeholders understand the information
provided in this final guidance document.
Following a brief presentation, the FDA will respond to
questions regarding this guidance document.
Following the webinar, a transcript, recording and slides will be
available at: FDA's site. The slide presentation will be available at this site on the morning of the
webinar.
Dial-in to hear the presentation and ask questions:
Call-in: 1-888-603-7015; Access code: 3007138
International Call-in: 1-517-308-9255; Access code: 3007138
The National Heart, Lung, and Blood Institute (NHLBI) announces a pilot program to encourage Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees that are developing and testing technologically innovative or substantial risk medical devices (diagnostics or therapeutics) to engage in early face-to-face interactions with the FDA Center for Devices and Radiological Health (CDRH).
NHLBI Pilot
Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical
Devices (Diagnostics and Therapeutics) (Admin Supp)
Companies selected for supplement awards can anticipate an NHLBI-facilitated introduction to a CDRH Coordinator in the appropriate CDRH review division where their technology will be regulated. The CDRH Coordinator will:
- Introduce the company to the US regulations relevant to the selected technology
- Talk with the company to more fully understand the technology under development
- Describe the process of CDRH regulation for the technology type
- Frame the conversation for a face-to-face meeting
- Engage appropriate CDRH Senior managers and review staff members with technology-relevant expertise to participate in a face-to-face meeting
Thursday, August 18
1:00 PM - 2:00 PM EST
Webinar Details: HERE
Diagnostics:
Use of Standards in FDA Regulatory Oversight of Next
Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for
Diagnosing Germline Diseases (http://bit.ly/2a3Pqq3)
Use of Public Human Genetic Variant Databases to Support
Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro
Diagnostics (IVDs) (http://bit.ly/29HQafb)
Principles for Codevelopment of an In Vitro Companion
Diagnostic Device with a Therapeutic Product (http://bit.ly/29DA7PW).
Devices:
Information to Support a Claim of Electromagnetic
Compatibility (EMC) of Electrically-Powered Medical Devices (http://bit.ly/29Unl3d)
Biologics:
Early Clinical Trials with Live Biotherapeutic Products:
Chemistry, Manufacturing, and Control Information (http://bit.ly/29Itxx8)
Drugs:
Charging for Investigational Drugs Under an IND Q&A (http://bit.ly/29YCrD4)
Expanded Access to Investigational Drugs for Treatment Use
Q&A (http://bit.ly/29Wpddp)
Chronic Obstructive Pulmonary Disease: Developing Drugs for
Treatment (http://bit.ly/29WsvNV)
Dial-in to hear the presentation and ask questions:
Call-in: 1-877-917-9491; Access code: 5995433
International Call-in: 1-212-287-1619; Access code: 5995433
The next NIH Small Business
Innovation Research (SBIR) and Small Business Technology Transfer (STTR)
Omnibus funding opportunity deadline is September 6, 2016. The National
Heart, Lung, and Blood Institute (NHLBI) welcomes all investigator-initiated
projects within our mission through the Omnibus funding
opportunities:
-
SBIR (PA-16-302)
and STTR (PA-16-303) Omnibus Solicitations for Phase I,
Phase II, and Fast-Track applications
-
SBIR
Direct-to-Phase II
Pilot (PAR-14-088)
for Direct to Phase II applications.
Note: the standard SBIR/STTR
due date of September 5th falls on a Federal holiday, so the deadline for
SBIR/STTR will be September 6th at 5 pm, your local time.
Get Ready
Additional
Funding Opportunities Due Fall 2016
-
September
6 - New Technologies for Viral Hepatitis (SBIR PA-15-077
STTR PA-15-076)
-
September
6 - Commercialization Readiness Pilot (CRP) Program: Technical Assistance for Phase II Awardees - (SB1 PAR-16-026,
Notice about NHLBI participation NOT-HL-15-283)
-
October
14 – Bioreactors
for Reparative Medicine (SBIR RFA-HL-15-008 STTR RFA-HL-15-004
D2P2 RFA-HL-15-017)
-
October
15 - Onsite
Tools and Technologies for Heart, Lung, and Blood Clinical Research
Point-of-Care (STTR RFA-HL-14-017)
-
November
9 – Human
Cellular Models for Predicting Individual Responses to Cystic Fibrosis
Transmembrane Conductance Regulator- Directed Therapeutics (SBIR RFA-HL-15-027)
View all NHLBI targeted
funding opportunities on our website (http://bit.ly/NHLBI-SBIR-FOA).
Monday, Sept. 12 at 8:00 AM
Tuesday, Sept. 13 at 8:00 AM
REGISTER HERE
The purpose of this workshop is to provide investigators
with training and expertise in designing and conducting clinical trials in
pediatric patients that will lead to appropriate labeling. Although we have
learned a lot about conducting pediatric trials over the past two decades,
there are still challenges that need to be addressed. The training course is
intended to provide investigators with:
(1) A clear understanding of some of the challenges of
studying products in the pediatric population, including: Pediatric study
design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial
design, formulations;
(2) an overview of extrapolation as it relates to the
pediatric population; and
(3) an overview of ethically appropriate methods related to
the design of clinical trials in the pediatric population
Interested parties can attend in person (at the Bethesda
Doubletree) or via webcast.
DoubleTree by Hilton Hotel Bethesda - Washington DC
8120 Wisconsin Avenue, Bethesda, MD 20814 - View Map
For more information, please
visit U.S. Food
and Drug Administration (FDA).
The NHLBI accepts
investigator-initiated grant applications relevant to the NHLBI mission through
the Omnibus Grant Solicitations. NHLBI has identified specific Topics of Special Interest though
we also encourage mission-aligned applications for innovative technologies
outside these targeted areas. Applications
for TOSI are submitted in response to the Omnibus Grant Solicitations (SBIR PA-16-302, STTR PA-16-303, and Direct to Phase II SBIR PAR-14-088).
TOSI are not the same as the
list of topics approved for awards over statutory budget limitations; for these
waiver topics, please see Appendix A of the Program Descriptions and Research
Topics document.
9/13 - RESI 2016
– Boston, MA
9/19 - 9/20 - Arizona
Bioscience Week (AZBio) – Phoenix, AZ
9/29 - 9/30 - 14th
Annual Dartmouth Device Development Symposium – Woodstock, VT
10/17 - 10/19 - AdvaMed 2016 –
Minneapolis, MN
10/18 - 10/19 - BIO Investor Forum –
San Francisco, CA
11/1 - NHLBI
Innovation Conference – New York City, NY
11/1 - 11/3 - SSTi
2016 Annual Conference – Columbus, OH
11/2 - 11/3 - Life
Sciences Summit – New York City, NY
11/13 - 11/15 - Partnering
for Cures – New York City, NY
11/15 - 11/17 - 18th Annual HHS SBIR/STTR Conference - Orlando, FL
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