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New Analysis Says FDA Farm Antibiotic Reduction Won't Work As Planned | WIRED

New Analysis Says FDA Farm Antibiotic Reduction Won't Work As Planned | WIRED | FDA Guidance | Scoop.it
A just-published analysis says pharma companies are evading the FDA's hoped-for curbs on antibiotic use in meat production.
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Mixing Medications and Dietary Supplements Can Endanger Your Health

Mixing Medications and Dietary Supplements Can Endanger Your Health | FDA Guidance | Scoop.it
Is mixing medicines and dietary supplements a good idea? Find out how using them together can endanger your health and why it's important to discuss them with your health care professional.
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FDA Focuses on Sex-Specific Data in Medical Device Clinical Trials - The National Law Review

FDA Focuses on Sex-Specific Data in Medical Device Clinical Trials - The National Law Review | FDA Guidance | Scoop.it
FDA Focuses on Sex-Specific Data in Medical Device Clinical Trials The National Law Review The guidance outlines “FDA's expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information.” According to the...
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FDASIA Section 907: Inclusion of Demographic Subgroups in Clinical Trials

Resource page related to FDASIA Section 907 (.@DrTaha_FDA: All for it! Greater Inclusion of Demographic Subgroups in Clinical Trials is needed.
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The FDA’s Consent Form Language – ‘Understandable’ or Not?

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Anyone involved in the informed consent process for a clinical study appreciates the challenge of explaining esoteric concepts in general...
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FDA Targets Companies for Facebook 'Likes.' Is Twitter Next? | RAPS

FDA Targets Companies for Facebook 'Likes.' Is Twitter Next? | RAPS | FDA Guidance | Scoop.it
Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might soon be focused there.
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Draft FDA Guidance for Informed Consent

Draft FDA Guidance for Informed Consent | FDA Guidance | Scoop.it
The FDA proposed replacing its 17-year old guidance on informed consent with a newer version. Jim Gearhart review's the changes.
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Draft FDA Guidance: Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors

Draft FDA Guidance: Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors | FDA Guidance | Scoop.it
FDA issued a guidance entitled: “Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors” earlier this week.
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FDA offers new draft guidance on informed consent process

FDA offers new draft guidance on informed consent process | FDA Guidance | Scoop.it
For the first time since 1998, the US FDA is offering draft guidance
on what it expects from IRBs (institutional review boards), clinical investigators and sponsors regarding informed consent.
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FDA's social media guidance: Better late than never

FDA's social media guidance: Better late than never | FDA Guidance | Scoop.it

Not only are today's healthcare consumers and patients relying more on the Internet to seek out information, locate needed medical experts and keep up on latest research and treatments, they're also sharing what they learn through an increasing number of social media outlets, including Facebook and Twitter.

Social media technologies provide users with quick and fast sharing capability and the potential to reach a huge swath of other users. The sites also afford the same capabilities to healthcare providers, vendors, pharmaceutical companies, payers and everyone else within the healthcare industry.

 

To that end, it's nice to see the U.S. Food and Drug Administration (FDA) finally catch up with how consumers and patients are sharing information online, especially since medical device manufacturers, pharma companies and other healthcare professionals are are doing the exact same thing.

In drafting a new federal guidance document on social media use, FDA offers medical device manufacturers and pharmaceutical companies insight on how to share benefit and risk information on 23 electronics digital platforms, ranging from Twitter and blogs to online paid search programs. Specifically, it calls for a balance between risk and benefit information posted to online platforms.

The guidance arrived several months after the FDA announced its intention to track social media talk about product risks. "The objective of this requirement is to provide FDA with the resources needed to use social media to inform and evaluate FDA risk communications," a solicitation notice published to the Federal Business Opportunities website in March said.

Doctors, nurses, pharmacists and healthcare consultants from the U.S. make up most of the healthcare professionals who use Twitter, according to research by Creation Healthcare, a London-based research and training consultancy. U.S. healthcare professionals make up 31 percent of the 75,000 worldwide total of healthcare professionals who turn to the social media site to "tweet" information about healthcare policy, research, individual medicines and treatments for the disease.

Still, social media, in general--for med device and pharma companies, as well as health payers and providers--is about actively influencing consumers, educating and empowering them to drive measurable results, according to a Deloitte University Press article published earlier this year.

 


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Erado Press's curator insight, July 8, 10:43 AM

FDA offers medical device manufacturers and pharmaceutical companies insight on how to share benefit and risk information on 23 electronics digital platforms, ranging from Twitter and blogs to online paid search programs. Specifically, it calls for a balance between risk and benefit information posted to online platforms.

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FDA Twitter guidance greeted with caution

FDA Twitter guidance greeted with caution | FDA Guidance | Scoop.it
Guidance on promoting products in 140 characters and correcting misinformation serves as a guarded green light, says one observer.
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Quorum Review receives reaccreditation from the Association of Human Research Protection Programs, Inc. (AAHRPP)

Quorum Review receives reaccreditation from the Association of Human Research Protection Programs, Inc. (AAHRPP) | FDA Guidance | Scoop.it
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FDA offering clinical trials for pets battling diseases

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The Food and Drug Administration is offering pets clinical trials to treat their diseases and gain insight into medical treatments for people.
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FDA Issues Draft Guidance on Rare Pediatric Diseases - Pharmaceutical Technology

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.
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It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS

It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS | FDA Guidance | Scoop.it
The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.
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Don't Leave Childhood Depression Untreated - FDA.gov

Don't Leave Childhood Depression Untreated - FDA.gov | FDA Guidance | Scoop.it
Don't Leave Childhood Depression Untreated
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“There are multiple parts to mental illness, and the symptoms are usually what drug companies study and what parents worry about.
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New FDA Pilot Program Wants to Make Keeping Track of Device Submissions Simple | RAPS

New FDA Pilot Program Wants to Make Keeping Track of Device Submissions Simple | RAPS | FDA Guidance | Scoop.it
A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance.
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FDA Finalizes Guidance For Home-Use Medical Devices

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The FDA recently released guidance for manufacturers on design considerations for medical devices intended for use at home to address the unique...
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FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics | RAPS

FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics | RAPS | FDA Guidance | Scoop.it
The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates.
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National Law Review: latest business law news and legal analysis

The National Law Review. Legal Analysis. Expertly Written by Leading Lawyers and Business Professionals. Quickly Found with no log in.
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FDA Releases 33 New Medical Device Standards | RAPS

US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards.
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FDA Outlines Regulatory Approach for Nanotechnology | RAPS

FDA Outlines Regulatory Approach for Nanotechnology | RAPS | FDA Guidance | Scoop.it
The US Food and Drug Administration (FDA) has finalized a 2011 guidance document outlining its regulatory approach for nanotechnology products, including medical products.
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U.S. FDA proposes social media guidelines for drug industry

U.S. FDA proposes social media guidelines for drug industry | FDA Guidance | Scoop.it
WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Tuesday issued proposed guidelines for the pharmaceutical and medical device industries for posting information on social media networks
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