June 2018 Drug and Device Corner

Federal Register Notice Vol 83, No. 108

FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the FD&C Act permitting the exemption of a device from the requirement to submit a 510(k).

FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity

[6/21/2018] The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a draft guidance for industry entitled “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product. After considering public comments that the agency received about the draft guidance, the FDA determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved. Comments submitted to the docket addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation. The FDA believes that in better addressing these issues in the future, the agency can advance principles that can promote a more efficient pathway for the development of biosimilar products.

The agency intends to issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.

Guidance Document updates on the FDA website

All Centers

Medical Product Communications That Are Consistent With the FDA-Required Labeling – Q & A

CDER

Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis

Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief

Complicated Urinary Tract Infections: Developing Drugs for Treatment

Assessment of Pressor Effects of Drugs

Complicated Intra-Abdominal Infections: Developing Drugs for Treatment

Major Depressive Disorder: Developing Drugs for Treatment

CDER & CBER

Limited Population Pathway for Antibacterial and Antifungal Drugs

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Development of a Shared System REMS

Waivers of the Single, Shared System REMS

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management – Core Guideline

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management – Annex

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products

CDRH

Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests

Intravascular Catheters, Wires and Delivery Systems with Lubricious Coatings – Labeling Considerations

Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling

Humanitarian Device Exemption (HDE) Program

Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions

CDER & CDRH

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities Q & A

CDER & CBER

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Q & A

Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

CVM

General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals

Posted in 2018 July, Drug and Device Corner.