MHRA announces new guidance on reporting suspected adverse drug reactions in children and neonates

MHRA has announced new simplified guidance for healthcare professionals reporting suspected adverse drug reactions (ADRs) in children to its Yellow Card Scheme.

Changes to the guidelines follow a recent workshop with paediatric specialists, healthcare professionals and patient organisations who concluded that reporting all suspected ADRs in children was considered impractical for busy healthcare professionals and potentially acted as a barrier to reporting.

The new guidance is simpler and aligned with the reporting guidelines for adults. It asks that healthcare professionals report all suspected ADRs that are serious, medically significant or result in harm, and all those that are associated with newer drugs and vaccines identified by the black triangle symbol.

This guidance applies to medicines, vaccines, herbal or complementary products, whether self-medicated or prescribed, and includes suspected ADRs associated with misuse and unlicensed medicines.

It also places greater importance on the reporting of medication errors in children resulting in suspected ADRs, and provides information on why reporting these reactions in children and neonates is particularly important.

Director of Vigilance and Risk Management of Medicines, Dr June Raine said:

“We strongly encourage healthcare professionals to help improve adverse drug reaction data by reporting suspected adverse drug reactions in children and neonates using the new simplified guidance.

“The effects of medicines in children can be different to adults and in order to widen our knowledge on any possible side effects in this young age group for existing and new drugs, it is vital that we receive reports.

“The quickest way to send a Yellow Card is online at mhra.gov.uk/yellowcard. Healthcare professional should inform patients about the Scheme and encourage them to also report themselves.”

Dr Hilary Cass, President of the Royal College of Paediatrics and Child Health, said:

“Reporting adverse reactions quickly and accurately is key to ensuring medicines are safe and effective for children and young people. These new guidelines should help speed up the process and mean that healthcare professionals are not put off by complex forms and unclear processes  The key message is – if you suspect a serious adverse drug reaction in a child – it must be reported and the best way of doing so it via the online Yellow Card.”

For details on Guidance Document CLICK HERE

USFDA CDER Guidance Document : Custom Device Exemption...

A guidance document has been posted regarding the Custom Device Exemption. 

The Food and Drug Administration (FDA) has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in Section 520(b) the Food, Drug and Cosmetic Act (FD&C Act). 

The guidance provides definitions of terms used in the custom device exemption, explains how FDA interprets the “5 units per year of a particular device type” language contained in section 520(b)(2)(B) of the FD&C Act, describes what information should be submitted in a Custom Device Annual Report (“annual report”), and provides recommendations on how to submit an annual report for devices distributed under the custom device exemption.  

To view/download the guidance, please CLICK HERE

USFDA: CDRH Industry: Announcing Final Guidance and FDA Webinar on Evaluation of Sex-Specific Data in Medical Device Clinical Studies

Today the Food and Drug Administration (FDA) posted a final guidance document, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” in combination with the FDASIA Section 907 Action Plan. The FDA’s final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents. The action plan focuses on three over-arching priorities: Data Quality, Subgroup Participation, and Data Transparency. 

Certain medical products may elicit different responses in women than men and these variables may affect the safe and effective use of medical devices. The FDA’s final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents.

The final guidance provides recommendations to medical device industry and FDA staff on:

• Enrollment: Recommended methods for designing and conducting clinical studies to encourage enrollment of both sexes.
• Analysis: Recommended methods for analysis of demographic data.
• Reporting: Recommended approaches for reporting of demographic data for device studies in the labeling and other public documents for approved or cleared devices.
• Decision frameworks for sex-specific study design, and for considering sex-specific data when analyzing and interpreting overall study outcomes, including when additional data may be needed.

On August 25, 2014 the FDA will hold a webinar to explain the guidance and to provide an opportunity to ask questions.  Registration is not necessary.

Webinar Details:

Date: August 25, 2014

Time: 3:00 PM – 4:30 PM, Eastern Time
To ensure you are connected, log-in at 2:45 PM.

To hear the presentation and ask questions:  

Dial: 1-888-282-0359; passcode: 7984204

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join/
Conference number: PW8306676 
Passcode: 798204
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm

Please Note: the slide presentation will also be available at this site on the morning of the webinar.

If you have any questions regarding this guidance, please contact one of the following at FDA/CDRH:

• Jismi Johnson (Biomedical Engineer, ODE), jismi.johnson@fda.hhs.gov
• Lilly Yue (Deputy Director, OSB/Division of Biostatics), lilly.yue@fda.hhs.gov
• Nilsa Loyo-Berrios (Deputy Director, OSB/Division of Epidemiology), nilsa.loyo-berrios@fda.hhs.gov
• Robert Becker (Chief Medical Officer, OIR), robertl.becker@fda.hhs.gov)
• Katie O’Callaghan (Senior Health Science Advisor, OCD), kathryn.ocallaghan@fda.hhs.gov
• The Division of Industry and Consumer Education (DICE) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov

Food and Drug Administration
Center for Devices and Radiological Health

FDA issues Guidance on the Unique Device Identification System: Frequently Asked Questions, Vol. 1

Today the Food and Drug Administration is making available Unique Device Identification System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff. FDA is issuing this document as level 2 guidance consistent with FDA’s good guidance practices regulation. While Level 2 guidance documents are posted for immediate implementation, comments on any guidance document may be submitted by following the instructions in theregulation. This guidance represents the FDA's current thinking on this topic.

Specifically, this guidance is intended to summarize key aspects of the UDI final rule, as identified through inquiries frequently submitted to the FDA UDI Help Desk. It addresses UDI basics, UDI placement, the Global Unique Device Identifier Database (GUDID), and direct marking, as well as exceptions, alternatives and exemptions.

At its most basic, the Unique Device Identification System requires device labelers (usually manufacturers) to include a unique device identifier (UDI) on the labels and packages of medical devices distributed in the United States, unless the FDA grants an exception or alternative. The UDI must be displayed in both easily readable plain-text and Automatic Identification and Data Capture (AIDC) technology – companies frequently have chosen to use a bar code. The UDI Rule also requires labelers to submit specified product information to FDA’s GUDID. Implementation of the rule will be phased in over seven years. For information on the benefits of the Unique Device Identification System please see the UDI website.

We hope you find this guidance useful and if you have any questions related to the implementation of the UDI rule please contact the FDA’s UDI Help Desk.

FDA issued a final Guidance Document on “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.”

The Food and Drug Administration (FDA) has recently issued a final guidance document, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.” The FDA is committed to improving US patient access to new devices by strengthening and streamlining the clinical trial enterprise so that clinical trials are conducted in the US in an efficient, cost-effective manner while maintaining appropriate patient protections.
The final guidance describes the FDA’s decision-making and communications regarding applications from companies that want to conduct medical device clinical trials in the US. It also describes more flexible options for clinical study approvals that allow clinical studies to begin sooner while ensuring patient protections.
 The final guidance outlines:
Processes to allow more efficient study enrollment
 Provides information regarding the FDA’s decision-making processes to improve predictability of the regulatory process
Introduces communication intended to improve the transparency of FDA’s decision-making process
On September 4, 2014 the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions you may have. Registration is not necessary.
Webinar Details:
Date: Thursday, September 4, 2014
Time: 1:00 PM – 2:30 PM, Eastern Time
To ensure you are connected, log-in by 12:45 PM.
To hear the presentation and ask questions: 
Dial: 888-972-7807; passcode: 1405152

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW8306690
Passcode: CDRH
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm