FDA News and Views: Interoperability, Public Engagement in Regulatory Framework, Therapeutic Protein Products
FDA BRIEF: Week of September 2, 2017
Interoperability: FDA’s Final Guidance on Smart, Safe, Medical Device Interactions
Health care providers and their patients rely om interactions among different medical devices
- Medical device interoperability
- Devices talk to each other in a safe and effective way enabling smarter care
FDA issued final guidance on medical device interoperability
- Design their devices with interoperability as an objective
- Conduct appropriate verification, validation and risk management activities
- Specify relevant functional, performance, interface characteristics to user
Webinar on Oct 26 to discuss Agency’s recommendations for developing safe and effective devices that exchange and use patient information electronically
FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework
By: Anna Abram, FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis
FDA’s policy efforts rooted in mission to protect and promote the public health, foster safe and effective innovations to benefit patients
- Explore ways to modernize regulations
- New regulations or policies to fulfill public health responsibilities
- Revise, update, eliminate existing regulations
- Regulatory framework that uses efficient and modern tools
Large undertaking given 100-plus year history
- Since its founding in 1906, scope and charge of work has grown
- Also assumed an increasingly global footprint
- Regulations comprise > 4,000 pages in Code of Federal Regulations
- Some are outdated – do not reflect advances in science & technology, reflect non-existing products/ptactices
- Goal to have regulations reflecting modern risks and opportunities
Reshape regulations to achieve our public health objectives
- Solicit feedback from patients, consumers, health providers, caregivers, industry, health groups, academia
- Aligns efforts with the Administration-wide goal to improve how government serves American people
Related: COMMISSIONER”S REMARKS
FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products
FDA scientists have great interest in chemical reaction in therapeutic protein products
- Can have a significant impact on protein function
- Can directly impact the quality, safety, and efficacy of protein products
Research by CDER Office of Biotechnology Products (OBP)
- Investigate exact locations of oxidative reactions within large protein molecules
- Focus on Protein Carbonylation, which entails the addition of a single atom of oxygen from environment, to discrete carbon atoms within protein molecules
- Refine antibody-binding assay taking advantage of “carbonyl group” reactivity
Findings
- Different proteins undergo carbonylation at different levels at specific sites
- Rate and site of carbonylation epend on temperature, time, and other variables
- Certain additives in drug formulations start or speed up these reactions
- Findings may help protein drug developers produce therapeutic proteins under optimized manufacturing conditions to prevent harmful carbonylation reactions
Image credit: FDA