FDA Los Angeles District Office and Orange County Regulatory Affairs Discussion Group
18th Annual FDA-OCRA Educational Conference *
June 3, 2015 Irvine, California
Speaker | Topics | Highlights |
---|---|---|
Steve Porter - FDA Los Angeles District, Acting District Director |
FDA Update | Top priority: Food Safety Modernization Act (FSMA) “Proactive and Preventative” 1) Evaluate Hazards 2) Think what are the preventative steps: documentation of monitoring must be available for FDA inspector 3) Inspection and compliance Foreign inspection included; plan to do 9,600 foreign inspections next 5 years 4) Import Food Safety: Foreign Suppliers must hold the same standard as US domestic suppliers so that US customers will not go for cheaper foreign made products. 5) Response: FDA has the authority to recall, if companies do not voluntarily recall. FDA will charge the costs to the Company. 6) Expenses: FDA will charge companies for :Re-inspection if no corrections made since the first inspection; Cost of recalls and subsequent inspection fees; Imports recall and re-exportation charges 7) Imports: third party certification by FDA authorized party; High-risk imports must come with 3rd party Certification 8) Importer: FDA has authority to deny entry only with presumption of suspicion and no Lab tests are needed 9) FSMA timetable: Foreign Supplier Verification: Large firms ? by 2017, medium ? 2018, small ? 2019 10) FDA strategy going forward: Specialization Field inspectors will be specialized; no loss of time before inspections; each FDA District will be assigned a specialty area. |
D. Olivier - Certified Compliance Solutions Mike Swit, Illumina |
FDA Regulation of Mobile Medical Applications | Which Mobile Medical App. does FDA regulate? FDA Guidance Mobile Medical Applications (Feb 2015) If an App is for a medical device, then FDA regulates. Regulatory submission of Mobile Medical Device Application Important: User manual, Software interfaces, Cyber-security integrity |
N. Dowell -International Vitamin Corp. |
Working with Dietary Supplement Contract Manufacturer (CM) | Product owner must select high quality CM: owner is ultimately responsible for the products in commerce. Regulatory challenges: Organic Product, Organic Crops, Gluten Free, Calif. Prop 65, Non-GMO etc. Useful FDA Guidance for both CM and product owner: Contract Manufacturing Arrangement for Drugs: Quality Agreements(PDF) |
J. Joseph -Joy’s Quality Management Systems | Industry Challenges to Implementation of New rules resulting from FSMA | Existing: 21 CFR part 110 (1986) Food cGMP New: 21 CFR part 117 (proposed); important: Subpart C Hazard Analysis Applicable to both Domestic and Foreign facilities Foreign Supplier Verification Program (FSVP) FDA accreditation of 3rd party audits: the supplier must meet FDA standards, Audit records need to be in English |
N. Guthrie -KGK Synergize |
Clinical Study Design for claim substantiation for Dietary Supplements | (1) What are your desired claims? (2) Select the right Target study population; for US clinical studies, must choose "healthy" subjects; Healthy subjects who are looking to improve some aspects of their health (3) Study endpoint should not be disease end point; use a surrogate endpoint or a marker "Avoiding Regulatory Nightmare; Study Endpoints and Claims, Substantiation for Clinical Trials"(Free white paper) |
* Please note that this is an educational conference. Both public and private presenters discussed regulatory aspects of product development. The organizers are not endorsing the presenter’s services.