FDA Brief: Week of Jan 25, 2016
New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016
CATEGORIES:
Advertising, Biopharmaceutics, Clinical/Antimicrobial, Clinical/Medical, Clinical Pharmacology, Clinical/Statistical, Electronic Submissions, Labeling, Pharmaceutical Quality/CMC, Pharmaceutical Quality/Manufacturing Standards (CGMP), Pharmacology/Toxicology, Procedural,
NOTABLES:
- Health Care Economic Information in Promotional Labeling and Advertising
- Treatment/Prevention of Anthrax, Attachment to HIV-1 Infection, Bacterial Vaginosis, Chronic Hepatitis C Virus Infection, Recurrent Herpes Labialis, Vulvovaginal Candidiasis, Allergic Rhinitis, Exocrine Pancreatic Insufficiency, Rare Diseases, Nonallergic Rhinitis, Ulcerative Colitis
- Patient Reported Outcomes for Varicose Vein burden, COPD
- Adaptive Clinical Trial Design, Meta-Analysis for Safety
- Post-marketing Safety reporting
Design Considerations and Pre-market Submission for Interoperable Medical Devices
- Interconnectivity of medical devices characterized as “interoperability.”
- Interoperability – Ability of two or more products, technologies or systems to exchange information and use of exchanged information
- Highlights:
- designing systems
- performance testing and risk management activities
- specifying functional, performance, and interface characteristics in labeling
Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator (CES)
Intended To Treat Insomnia and/or Anxiety : Class III to II – 510(k)
Intended To Treat Depression : PMA
Recalssification based on deliberations of 2012 Panel meeting, reclassification petitions and new information that there is sufficient information to establish special controls to mitigate risks.