Monday, October 17, 2016

FDA Updates for Health Professionals

ANNOUNCEMENTS
OPPORTUNITIES FOR COMMENT / GUIDANCES
PRODUCT APPROVALS & CLEARANCES
PRODUCT SAFETY
UPCOMING MEETINGS
RESOURCES

ANNOUNCEMENTS

FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form

FDA finalized its efforts to streamline the process used by physicians to requestexpanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition. More information

Problems with E-Cigarettes, Vape Products, Hookah, Cigarettes or Tobacco? Tell FDA

FDA wants to hear from you—and has updated the online toolyou can use to report a problem. The Department of Health and Human Services’ Safety Reporting Portal (SRP) provides a standardized way for consumers, health care professionals, manufacturers, and clinical investigators to let FDA know about an unexpected health or safety issue with a tobacco product.More information.

FDA To Hold Webinar on Guidance for Voluntarily Reducing Sodium

FDA) will host a webinar on Tuesday, June 21, 2016, to review our draft guidance that provides voluntary sodium reduction targets for the food industry. FDA issued the guidance on June 1, 2016. Registration is not required. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act

These guidance documents explain FDA’s policy regarding the conditions under which the agency does not intend to take action against state-licensed pharmacies, federal facilities, and licensed physicians (under section 503A) or outsourcing facilities (under section 503B) that compound drug products from bulk drug substances that cannot otherwise be used in compounding under these sections. More information

Use of Symbols in Labeling

FDA is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. More information

Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition Draft Guidance: Dissemination of Patient-Specific Information from Devices by Device Manufacturers

The purpose of this guidance is to clarify that that FDA requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved and/or derived from a medical device with the patient who is either treated or diagnosed with that device. We hope that clarification of this policy will help patients receive access to accurate, usable information from medical devices so that they can be more engaged with their healthcare providers in making sound medical decisions. More information

Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period

FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016. More information

Draft Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods

FDA issued a draft guidance for public comment that provides voluntary sodium reduction targets for the food industry. The draft short-term (2-year) targets seek to decrease sodium intake to about 3,000 mg per day. The long-term (10-year) targets seek to reduce sodium intake to 2,300 milligrams per day. The targets, which cover nearly 150 food categories, are intended to complement many existing efforts by food manufacturers, restaurants and food service operations to reduce sodium in foods.More information

FDA’s final guidance: “Postmarket Surveillance Under Section 522 of the Federal Food, Drug & Cosmetic Act”

Section 522 of the Federal, Food, Drug and Cosmetic Act (the Act) provides the FDA with the authority to require device manufacturers to conduct postmarket surveillance of certain class II or class III devices. This guidance document clarifies the 522 postmarket surveillance process and provides manufacturers with information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions. More information

Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some of the prior responses. More information

Use of Electronic Health Record Data in Clinical Investigations; Draft Guidance for Industry

The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance aims to facilitate use of electronic health record (EHR) data in clinical investigations and to promote the interoperability of EHRs and electronic systems supporting the clinical investigation. More information

Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers

FDA is issuing this draft guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance characteristics of Infectious Disease Next Generation Sequencing Based Diagnostic Device for Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers (hereafter referred to as “Infectious Disease NGS Dx devices”). Infectious Disease NGS Dx devices are for use as aids in the diagnosis (identification) of microbial infection and in selecting appropriate therapies. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves vaccine to prevent cholera for travelers

FDA approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera. More information

FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC). More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed

PRODUCT SAFETY

Need Safety Information?

For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings

FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. More information

Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse

FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide. More information

Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk

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