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16th Annual NIH SBIR/STTR Conference
Functional Down-to-Earth Advice for understanding the FDA
Chris Sasiela, PhD, RACNHLBI Office of Translational Alliances and Coordination
How the FDA is organized How drugs, biologics, and medical devices
are regulated Where to start Where to go for help Office of Special Medical Programs
Learning Objectives
How the FDA is organized How drugs, biologics, and medical devices
are regulated Where to start Where to go for help Office of Special Medical Programs
Learning Objectives
FDA Organization
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OrganizationCharts/UCM291886.pdf
Office of Medical Products and Tobacco
Center for Biologics Evaluation and
Research
Center for Drug Evaluation and
Research
Center for Devices and Radiological Health
Center for Tobacco Products
Office of Special Medical Programs
Practical FDA for biomedical innovators
Center for Biologics Evaluation and Research
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123224.htm
Office of the CBER Director
Office of Blood Research and Review
Office of Vaccines Research and Review
Office of Cellular, Tissue and Gene Therapies
Practical CBER for biomedical innovators
Organized by therapeutic modality
Office Products Regulated
OBRR Blood and blood components used for transfusion, such as red blood cells, plasma, and platelets. Pharmaceutical products made from blood, such as clotting factors and immunoglobulins.Medical devices and tests used to safeguard blood, blood components, and cellular products from HIV, hepatitis, syphilis, and other infectious agents. Reagents used to type blood. Machines and related software used to collect blood and blood components.
OVRR Vaccines used for the prevention of infectious diseases, such as mumps, measles, chicken pox, diphtheria, tetanus, influenza, hepatitis, smallpox, and anthrax. Vaccines under development to treat HIV, and to treat or prevent non-infectious conditions, including various cancers.Patch tests used to diagnose the causes of contact dermatitis. Extracts used to diagnose and treat rhinitis ("hay fever"), allergic sinusitis and conjunctivitis, and bee stings.
OCTGT Human tissues for transplantation, such as skin, tendons, ligaments, and cartilage. Cellular products, such as human stem cells and pancreatic islets. Tissue and cellular products have the potential to treat cancer, Parkinson's disease, hemophilia, anemia, diabetes, and other serious conditions.Gene therapy products that replace a person's faulty or missing genetic material. Gene therapy research could lead to new treatments for cancer cystic fibrosis, heart disease, hemophilia, diabetes, and infectious diseases such as AIDS.Xenotransplantation products use live animal cells, tissues, or organs to treat human diseases such as liver failure and diabetes, where human materials are not always available.
De-coding Biologics
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133072.htm
Center for Drug Evaluation and Research
http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm403687.htm
Office of New Drugs
Office of Drug Evaluation I
Office of Drug Evaluation II
Office of Drug Evaluation III
Office of Drug Evaluation IV
Office of Antimicrobial Products
Office of Hematology and Oncology Products
Practical CDER for biomedical innovators
Organized (generally) by disorder or organ system
An ODE by any other name…
Office of Drug Evaluation Divisions
ODE Ihttp://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm290659.htm
Cardiovascular and Renal ProductsNeurology ProductsPsychiatry Products
ODE IIhttp://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm269644.htm
Anesthesia, Analgesia, and Addiction ProductsMetabolism and Endocrinology ProductsPulmonary, Allergy, and Rheumatology Products
ODE IIIhttp://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm252063.htm
Gastroenterology and Inborn Errors ProductsDermatology and Dental ProductsBone, Reproductive, and Urologic Products
ODE IV http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm106342.htm
Medical Imaging ProductsNon-prescription Clinical Evaluation (OTC)Non-prescription Regulation Development (OTC)
CDRH Management Directory by Organization
This information is current as of August 20, 2014.
Office of the Center DirectorOffice of Communication and EducationOffice of ComplianceOffice of Device EvaluationOffice of In Vitro Diagnostics and Radiological HealthOffice of Management OperationsOffice of Science and Engineering LaboratoriesOffice of Surveillance and Biometrics
Center for Devices and Radiological Health
http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhoffices/ucm127854.htm
Practical CDRH for biomedical innovators
Office of Device EvaluationAnesthesiology, General
Hospital, Respiratory, Infection Control, and Dental
Cardiovascular
Ophthalmic and ENT
Neurological and Physical Medicine
Orthopedic
Surgical
Reproductive, Gastro-renal, Urological
Office of In Vitro Diagnostics and Radiological Health
Chemistry and Toxicology Devices
Immunology and Hematology Devices
Molecular Genetics and Pathology
Microbiology Devices
Radiological Health
Mammography Quality Standards
Organized (generally) by disorder or organ system
Medical Specialties
Office of Device EvaluationAnesthesiology (868), General Hospital (880), Respiratory, Infection Control (862, 864, 866), and
Dental (872)
Cardiovascular (870)
Ophthalmic (886) and ENT (874)
Neurological (882) and Physical Medicine (890)
Orthopedic (888)
Surgical (878)
Reproductive (884), Gastro-renal (876), Urological (876)
How the FDA is organized How drugs, biologics, and medical devices
are regulated Where to start Where to go for help Office of Special Medical Programs
Learning Objectives
Regulated under the Public Health Service Act IND for clinical development Biologics License for marketing allowance Co-regulate many medical devices
specifically related to blood products
‘Biological Product'' a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Biologics Regulation
Federal Food, Drug, and Cosmetic Act as amended
- Orphan Drug Act (1983)- Drug Price Competition and Patent Term
Restoration Act (1984)- Best Pharmaceuticals for Children Act (2002)- Pediatric Research Equity Act (2003)- Food and Drug Administration Amendments Act
(2007)- Food and Drug Administration Safety and
Innovation Act (2012)
Drug Regulation
FD&C Act Medical Device Amendments- May 28, 1976
Title 21 Code of Federal Regulations Parts 800-1299 Classification based on risk
Class I Low Risk (General Controls) Class II Medium Risk (General Controls and Special Controls) Class III High Risk (General Controls and Premarket Approval)
Market allowance based on risk plus legislation Exempt,510(k), PMA
Tracking Establishment Registration Medical Device Listing Unique Device Identification
Device Regulation
How the FDA is organized How drugs, biologics, and medical devices
are regulated Where to start Where to go for help Office of Special Medical Programs
Learning Objectives
20
www.FDA.gov
CBER http://
www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm129132.htm
CDER http://
www.fda.gov/drugs/guidancecomplianceregulatoryinformation/ucm113237.htm
CDRH http://
www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHFOIAElectronicReadingRoom/default.htm
21
FOIA Electronic Reading Rooms
Biologics Products & Establishments Licensed Biological Products with Supporting
Documents Substantially Equivalent 510(k) Device Information Premarket Approvals (PMAs) and Humanitarian
Device Exemptions (HDEs) New Drug Applications (NDAs) Postmarketing Requirements and Commitments:
Introduction Transfer of Therapeutic Products to the Center for
Drug Evaluation and Research
CBER Product Approval Information
Licensed Biological Products with Supporting Documents
ALPROLIX (Biogen Idec)
Types of Supporting Information/Documents
BL 125444
Most current approval letterRationale for approval
In depth approval information!!
Understanding CBER Licensing Applications
Redacted documents
How do reviewers think?How did the company present their product?
(not all trials go into a license application)
What was the company’s pre-clinical and clinical strategy?
Product Approval Information Drugs @ FDA
CDER Product Approval Information
Basic Information
ND 205434
In depth approval information!!
What about the reviews?
This product was approved on July 23, 2014. This screenshot was taken August 20, 2014.Redaction and uploading of review information takes time!
CDRH Reading Room
510(k) Database
K140582
Product Information
Product Classification Information
510(K) Summary
Intended Use
Device Description
Comparison to Predicate- Basis of SE determination
Predicate Identification Sponsor
Conclusions
CBER OCTGT Learn http://www.fda.gov/biologicsbloodvaccines/newsevents/ucm232821.htm
CDER Learn http://www.fda.gov/Training/ForHealthProfessionals/default.htm
CDRH Learn http://www.fda.gov/Training/CDRHLearn/default.htm
34
FDA Educational Resources
FDA Small Business Guide http://
www.fda.gov/downloads/forindustry/smallbusinessassistance/smallbusinessguidetofda/ucm081030.pdf
FDA Small Business Contacts http://www.fda.gov/forindustry/smallbusinessassistance
/smallbusinessrepresentatives/
FDA Information update request page http://
www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm#top
35
General Websites of Interest
How the FDA is organized How drugs, biologics, and medical devices
are regulated Where to start Where to go for help Office of Special Medical Programs
Learning Objectives
CDER Small Business and Industry Assistance CDERSmallBusiness@fda.hhs.gov
(866) 405-5367 or (301) 796-6707
CBER Office of Communication, Outreach, and Development Industry.Biologics@fda.hhs.gov
(800) 835-4709 or (301) 827-1800
CDRH Division of Industry and Consumer Education DICE@fda.hhs.gov
(800) 638-2041 or (301) 796-7100
Small Business Assistance Offices
CBER Contacts http://www.fda.gov/AboutFDA/CentersOffices/Offi
ceofMedicalProductsandTobacco/CBER/ucm123224.htm
CDER Contacts http://www.fda.gov/aboutfda/centersoffices/office
ofmedicalproductsandtobacco/cder/ucm075128.htm
CDRH Contacts http://www.fda.gov/AboutFDA/CentersOffices/Offi
ceofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm
38
Center Contact Information
How the FDA is organized How drugs, biologics, and medical devices
are regulated Where to start Where to go for help Office of Special Medical Programs
Learning Objectives
Office of Special Medical Programs
Office of Combination Products
Office of Good Clinical Practice
Office of Orphan Products Development
Office of Pediatric Therapeutics
Cross-Center Offices
Guidance Documents Early Development Considerations for Innovative
Combination Products (09/2006) How to Write a Request for Designation (04/2011) Classification of Products as Drugs and Devices
and Additional Product Classification Issues (Draft - 06/2011)
combination@fda.hhs.gov
301-796-8930
Office of Combination Products
Designation Programs Orphan Drug designation
- including exclusivity HUD Designation Rare Pediatric Disease Designation
- for Priority Review Voucher Program
Grants Orphan Products Grants Program Pediatric Device Consortia Grants Program
Outreach Program Patient-related Topics
Orphan Product Development Programs
For (non-oncology) Orphan Drug Designations:
Jeff.Fritsch@fda.hhs.gov For (oncology) Orphan Drug Designations, Devices, and
Rare Pediatric Disease Designations:
James.Bona@fda.hhs.gov For Orphan Grants:
Mary.Limon@fda.hhs.gov For Pediatric Device Consortia Grants:
Linda.Ulrich@fda.hhs.gov
(301) 796-8660
Office of Orphan Product Development
Scientific Activities Program Clinical protocol design/conduct/lessons-learned
Ethics Program Necessity of proposed pediatric studies
Safety Program Coordinate Pediatric Advisory Committee
International Program Collaborate with other regulatory agencies
OPT@fda.hhs.gov
301-796-8659
Office of Pediatric Therapeutics
?Thank You
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