Recent Federal Register Postings
The following are summaries of the Federal Register notices published during FDA Webview’s holiday break:
ANIMAL DRUGS
Federal Register final rule: FDA has issued a final rule that amends the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under the rule, when FDA determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. To view the notice, click here.
DRUGS/BIOLOGICS
Federal Register notice: FDA has made available a draft guidance entitled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” The document replaces two previous guidances — “Formal Meetings Between the FDA and Sponsors or Applicants” published 5/2009 and “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” published 3/2015. To view the notice, click here.
Federal Register notice: FDA has made available a guidance entitled “Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate- Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.” The document finalizes recommendations for drug sponsors who wish to request a waiver of an in vivo bioavailability or bioequivalence study requirement. To view the notice, click here.
Federal Register notice: FDA has made available a guidance entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The document describes the agency’s philosophy on timely interactive communications and it outlines the types of advice appropriate for sponsors to request about their drug development programs. To view the notice, click here.
Federal Register notice: FDA has made available a draft guidance on “Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.” The document is intended to assist certain biologic makers in determining which reporting category is appropriate for a BLA change in chemistry, manufacturing, and controls information. It provides general and administrative information on reporting and evaluating changes and recommendations for reporting categories based on a tiered-system for specific changes. To view the notice, click here.
Federal Register notice: FDA is requesting nominations of patient advocates interested in participating on its Patient Engagement Collaborative (PEC). Under the PEC, the patient community and regulators will be able to discuss an array of topics about increasing meaningful patient engagement in medical product development and regulatory discussions at the agency. To view the notice, click here.
Federal Register notice: FDA has issued a debarment order against Keith J. Pierce for a period of five years to ban his services in any capacity that would involve an approved or pending drug product application. The debarment is related to conduct involving clinical trials for Aventis Pharmaceuticals’ Ketek (telithromycin) and its use in treating acute maxillary sinusitis. To view the notice, click here.
Federal Register final rule: FDA has issued a final rule that applies to health care antiseptic products that are intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. Health care antiseptic products include health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand rubs, and patient antiseptic skin preparations (i.e., patient preoperative and pre-injection skin preparations). To view the notice, click here.
Federal Register notice: FDA has made available a draft guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” FDA intends to no longer grant orphan drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of over 200,000 in the U.S.), unless the use meets the regulatory criteria for an orphan subset, or unless the disease in the pediatric subpopulation is considered a different disease from the disease in the adult population. To view the notice, click here.
Federal Register notice: FDA makes available a draft guidance entitled “Drug Products Labeled as Homeopathic.” The document describes how FDA intends to prioritize enforcement and regulatory action with drug/biologic products labeled as homeopathic and marketed in the U.S. without agency approval. To view the notice, click here.
Federal Register notice: FDA has made available a draft guidance entitled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” To view the notice, click here.
Federal Register notice: FDA has announced a public workshop entitled “New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products.” Officials at the workshop will present the outcomes from research projects conducted under the Generic Drug User Fee Amendments. The workshop is also intended to discuss how regulatory science initiatives have helped address regulatory science knowledge gaps by providing insights on factors that influence the performance of generic orally inhaled and nasal drug products. To view the notice, click here.
Federal Register notice: FDA makes available a draft guidance entitled “Information Requests and Discipline Review Letters Under GDUFA.” The document explains how FDA will issue and use an information request and discipline review letter during ANDA reviews. To view the notice, click here.
Federal Register notice: FDA has made available a draft guidance entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” To view the notice, click here.
Federal Register notice: FDA has made available a draft guidance entitled “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.” The document describes FDA’s current recommendations on how to group patients with different molecular alterations for eligibility in clinical trials. It also address general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies. To view the notice, click here.
MEDICAL DEVICES
Federal Register notice: FDA has classified the pressure wedge for reducing cesarean delivery into Class 2 (special controls). The de novo classification request was submitted 1/2016 by Stetrix, Inc. for its Hem-Avert Perianal Stabilizer. To view the notice, click here.
Federal Register notice: CDRH is announcing its “Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.” The program is intended to evaluate product and manufacturing quality within the medical device ecosystem. It also intends to evaluate the effectiveness of a quality maturity appraisal, quality metrics, optimization of resources, and the impact on quality culture. To view the notice, click here.
Federal Register notice: FDA has announced a 3/1 Neurological Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are expected to review clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. The meeting will also seek panel members’ opinions on the scientific and clinical considerations relating to the clinical trial designs for such devices. To view the notice, click here.
Federal Register notice: FDA has announced a proposed program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form. The Voluntary Malfunction Summary Reporting Program is intended to streamline malfunction reporting as outlined in the recently reauthorized medical device user fee agreement. The program’s goals include permitting certain device makers to summary report malfunctions on a quarterly basis. To view the notice, click here.
Federal Register notice: FDA has made available a draft guidance entitled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” The document is intended to assist sponsors and institutional review boards that review such investigations in complying with the Investigational Device Exemption regulation. To view the notice, click here.
Federal Register notice: FDA has made available entitled “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.” The document is intended to update and clarify the policy for a manufacturer’s application of an assay that was previously cleared for use based on performance characteristics with a specified instrument, to an additional instrument that was previously cleared or that is a member of an instrument family from which another member has been previously cleared. To view the notice, click here.