Sandra Sather
FDA Issues Warning Letter Regarding Patient ...

10/22/2024

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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.

FDA Issues Warning Letter Regarding Patient Overdose
Guest User
FDA Updates Guidance to Address the Spread of ...

10/10/2024

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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.

FDA Updates Guidance to Address the Spread of Misinformation
Sandra Sather
Real-World Data and Evidence Generation with ...

10/01/2024

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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.

Real-World Data and Evidence Generation with Dr. Hilary Marston
Sandra Sather
New Draft Guidance on Predetermined Change ...

09/18/2024

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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.

New Draft Guidance on Predetermined Change Control Plans for Medical Devices
Sandra Sather
FDA Announces Upcoming Webinar to Discuss the ...

09/10/2024

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In August 2024, the US Food and Drug Administration (FDA) released a final guidance for industry on drug-drug interactions (DDI) with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) titled: M12 Drug Interaction Studies. The guidance is intended to set the global standard and framework for conducting and reporting DDI studies in order to improve the efficacy of drugs as well as the safety and predictability of potential interactions between different drugs.

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

Finalized FDA and OHRP Guidance on Electronic Informed Consent!

12/22/2016

The FDA and the OHRP announced the finalized version of the regulatory guidance document for electronic informed consent (eIC) “Use of Electronic Informed Consent—Questions and Answers” December 2016. The guidance document represents the current thinking of these regulatory agencies and are recommendations, but like this one, sometimes include requirements where applicable. It is of note that the FDA and OHRP combined their guidance together into one document to support ongoing efforts to harmonize between the agencies. This is great news for those that consent under FDA regulated trials and / or government sponsored research! This emphasizes the point that an eIC solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies.

“Monitoring Electronic Health Records (EHRs): FAQ and - Understanding the Recent May 2016 FDA Draft Guidance - Attend the UPCOMING WEB Session”

12/19/2016

Date: Dec 19, 2016

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001

Description: 

In this session we will take an in depth look to the recent May 2016 FDA Draft Guidance as well as we will provide clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR) including

21st Century Cures Act: Making Progress on Shared Goals for Patients

12/13/2016

THE US 21ST CENTURY CURES ACT WAS SIGNED INTO LEGISLATION YESTERDAY.  PLEASE SEE THE ANNOUNCEMENT BELOW. 

TODAY, PRESIDENT OBAMA SIGNED INTO LAW THE 21ST CENTURY CURES ACT, WHICH, I AM PLEASED TO REPORT, BUILDS ON FDA’S ONGOING EFFORTS TO ADVANCE MEDICAL PRODUCT INNOVATION AND ENSURE THAT PATIENTS GET ACCESS TO TREATMENTS AS QUICKLY AS POSSIBLE, WITH CONTINUED ASSURANCE FROM HIGH QUALITY EVIDENCE THAT THEY ARE SAFE AND EFFECTIVE.

Read more here http://blogs.fda.gov/fdavoice/index.php/2016/12/21st-century-cures-act-making-progress-on-shared-goals-for-patients/?source=govdelivery&utm_medium=email&utm_source=govdelivery