* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Wednesday, July 2, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    Nantucket Dance Festival opens July 8 – The Inquirer and Mirror

    Nantucket Dance Festival Launches with Thrilling Performances Beginning July 8

    A Secret Society, Ritualistic Killings, and a Century-Old Curse Netflix and YRF Entertainment’s ‘Mandala Murders’ Premieres July 25 – About Netflix

    A Secret Society, Ritualistic Killings, and a Century-Old Curse: Dive into the Chilling World of ‘Mandala Murders’ Premiering July 25

    Susquehanna Raises Penn Entertainment Inc. (PENN) Price Target. – Yahoo Finance

    Susquehanna Raises Price Target for Penn Entertainment Inc. (PENN)

    George Lopez is coming to Spokane – KXLY.com

    George Lopez is coming to Spokane – KXLY.com

    Netflix unveils Dallas immersive venue for fans of hit shows like ‘Squid Game,’ ‘Stranger Things’ – Houston Chronicle

    Step Inside Netflix’s New Dallas Immersive Experience Featuring Hits Like ‘Squid Game’ and ‘Stranger Things

    ‘Puttin’ on the Ritz’: Civic Players bring ‘Young Frankenstein’ to life – Yahoo

    Civic Players Deliver a Hilarious and Unforgettable Performance of ‘Young Frankenstein

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

    Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

    Meiwu Technology Company Limited and Shenzhen Zhinuo – GlobeNewswire

    Meiwu Technology Company Limited and Shenzhen Zhinuo – GlobeNewswire

    Owls inspire new revolutionary noise reduction technology – KTEN

    Owls inspire new revolutionary noise reduction technology – KTEN

    New center coming to Mizzou will focus on energy research and technology – Columbia Missourian

    Mizzou Launches Innovative New Center Dedicated to Energy Research and Technology

    Mirrors in space and underwater curtains: can technology buy us enough time to save the Arctic ice caps? – The Guardian

    Can Technology Like Space Mirrors and Underwater Curtains Buy Us Time to Save the Arctic Ice Caps?

    Naples restaurant owner prepares for hurricane season with new flood technology – Fox4Now.com

    Naples restaurant owner prepares for hurricane season with new flood technology – Fox4Now.com

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    Nantucket Dance Festival opens July 8 – The Inquirer and Mirror

    Nantucket Dance Festival Launches with Thrilling Performances Beginning July 8

    A Secret Society, Ritualistic Killings, and a Century-Old Curse Netflix and YRF Entertainment’s ‘Mandala Murders’ Premieres July 25 – About Netflix

    A Secret Society, Ritualistic Killings, and a Century-Old Curse: Dive into the Chilling World of ‘Mandala Murders’ Premiering July 25

    Susquehanna Raises Penn Entertainment Inc. (PENN) Price Target. – Yahoo Finance

    Susquehanna Raises Price Target for Penn Entertainment Inc. (PENN)

    George Lopez is coming to Spokane – KXLY.com

    George Lopez is coming to Spokane – KXLY.com

    Netflix unveils Dallas immersive venue for fans of hit shows like ‘Squid Game,’ ‘Stranger Things’ – Houston Chronicle

    Step Inside Netflix’s New Dallas Immersive Experience Featuring Hits Like ‘Squid Game’ and ‘Stranger Things

    ‘Puttin’ on the Ritz’: Civic Players bring ‘Young Frankenstein’ to life – Yahoo

    Civic Players Deliver a Hilarious and Unforgettable Performance of ‘Young Frankenstein

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

    Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

    Meiwu Technology Company Limited and Shenzhen Zhinuo – GlobeNewswire

    Meiwu Technology Company Limited and Shenzhen Zhinuo – GlobeNewswire

    Owls inspire new revolutionary noise reduction technology – KTEN

    Owls inspire new revolutionary noise reduction technology – KTEN

    New center coming to Mizzou will focus on energy research and technology – Columbia Missourian

    Mizzou Launches Innovative New Center Dedicated to Energy Research and Technology

    Mirrors in space and underwater curtains: can technology buy us enough time to save the Arctic ice caps? – The Guardian

    Can Technology Like Space Mirrors and Underwater Curtains Buy Us Time to Save the Arctic Ice Caps?

    Naples restaurant owner prepares for hurricane season with new flood technology – Fox4Now.com

    Naples restaurant owner prepares for hurricane season with new flood technology – Fox4Now.com

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines

May 23, 2024
in Health
House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines
Share on FacebookShare on Twitter

With all the news about drug shortages, there’s another type of possible shortage that the public should be concerned with, an FDA official said Wednesday.

“We need help from Congress on our authorities to prevent device shortages,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said at a House Energy & Commerce Health Subcommittee hearing on FDA regulation of drugs, biologics, and devices. “They’re happening every day, and we don’t have all the tools we need to prevent that.”

Device shortages was one of a number of topics that came up during a wide-ranging hearing featuring FDA officials that lasted for several hours. One topic that had interest from members on both sides of the aisle was the FDA’s recent issuance of a final rule regulating laboratory-developed tests (LDTs) — in vitro diagnostic products designed, manufactured, and used within a single clinical laboratory. LDTs can be used to measure or detect markers like proteins, glucose, cholesterol, or DNA to help provide information about a patient’s health, including diagnosing, monitoring, or determining treatments.

“I’ve heard concerns that FDA regulation of LDTs could slow the approval process for all drugs and devices in addition to LDTs,” said Rep. Raul Ruiz (D-Calif.). “While FDA will not collect user fees for LDTs for years, there’s significant work that must begin now, including issuing guidance documents related to the rule.” He asked Shuren whether FDA had enough resources to carry out the new rule.

“So we do have the resources to begin implementation of that rule, and we’re already moving forward,” Shuren said. “We’re also looking at other opportunities for reducing costs, both to test makers and to the FDA,” including ways to streamline premarket review.

Rep. John Sarbanes (D-Md.) asked what the agency was doing to encourage more generic drugs to come onto the market. “This is an area that is critical for us,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Of course, the entire generic drug program is pointed towards making drugs more accessible to patients by creating competition and therefore lowering prices. This is a program that has historically had a lot of high volume; we are increasingly focusing on what we see is coming up in the pipeline for generics.”

There are things Congress could do to help things along, she added. “For instance, one of the problems that we encounter is what brand-name drug manufacturers use to stifle competition — constraints around what we can disclose to generic manufacturers when it comes to all of the ingredients in a drug. We have put forward some proposals to help remove some of those barriers,” said Cavazzoni.

Rep. Richard Hudson (R-N.C.) was concerned about the FDA’s failure to meet some of its own deadlines for deciding whether to approve a particular drug. Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, agreed that this was a problem. “We have a group that actually tracks these quite closely and … I agree with you. We can sometimes do better here,” he said. “We try to do, essentially, ‘after action’ [reports] to understand why these events occur, so we can help prevent them … Bureaucratic reasons for this are unacceptable. There has to be a good scientific reason why we miss things.”

Cavazzoni said it was “very rare” for her division to miss those deadlines, noting that if a drug sponsor wants to submit additional data while their application is being processed, “we extend the goal date to allow them to submit the data and allow it to be reviewed.”

On a related note, Rep. Robin Kelly (D-Ill.) asked about getting more diverse populations included in clinical trials. “It is very important that we enroll, in clinical trials, a population that is representative of the population that will ultimately be taking the drug once it’s marketed,” said Cavazzoni. “We’re paying a lot of attention to clinical trial diversity,” including by issuing guidance about who should be included.

On the other hand, “We don’t want the inclusion or exclusion criteria for trials to be so restrictive that it really impacts the generalizability of the data,” she said. “And lastly, it is very important that we find a way to actually have recruitment for clinical trials in the communities that have historically been excluded from clinical trials.”

Communication with the agency was another issue of concern. “One thing that has come to my attention in meeting with some really interesting innovators in the healthcare space is the lack of communication with FDA,” said Rep. Dan Crenshaw (R-Texas). “They often feel like it’s sort of a black hole of communication. They don’t know what they’re doing wrong — they’re just told to do it again, to try something differently.” He asked how the agency is supporting “smaller companies that don’t have legions of lawyers” to help them with the application process.

“We recognize that many of the sponsors working in regenerative medicine, even some of the small gene therapy companies — they do not have the experience dealing with [FDA] and need someone to listen to their concerns and respond,” said Marks, adding that the agency has several programs to help such companies.

For one program, “it may not be a [specific] product but a set of products they’re intending to develop, and they can have a very informal meeting with some of my colleagues about manufacturing or clinical development,” he said. Another program allows sponsors to “come in with just a couple of pages” about what they’re trying to develop, and get advice on how to do it. “It’s a ‘no fault’ dialogue — we don’t hold the sponsor to taking our advice, but it allows them to get feedback.”

author['full_name']

Joyce Frieden oversees MedPage Today’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy. Follow

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MedPageToday – https://www.medpagetoday.com/publichealthpolicy/fdageneral/110284

Tags: healthHousemembers
Previous Post

Will FDA Advisors Look Past Hypoglycemia Risk With Once-Weekly Insulin?

Next Post

Brain Risks Drop When Diet Includes More Minimally Processed Foods

Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

July 2, 2025
Diamondbacks ban fan who interfered with apparent would-be Giants HR for rest of season, citing ‘multiple offenses’ – Yahoo Sports

Diamondbacks ban fan who interfered with apparent would-be Giants HR for rest of season, citing ‘multiple offenses’ – Yahoo Sports

July 2, 2025
Late Paleolithic whale bone tools reveal human and whale ecology in the Bay of Biscay – Nature

Ancient Whale Bone Tools Reveal Secrets of Human and Whale Life in the Bay of Biscay

July 2, 2025
Exploring three theories of consciousness. – Psychology Today

Unveiling the Mysteries: Exploring Three Fascinating Theories of Consciousness

July 2, 2025
MIT student wins first-ever Stephen Hawking Junior Medal for Science Communication – MIT News

MIT student wins first-ever Stephen Hawking Junior Medal for Science Communication – MIT News

July 2, 2025
Here’s what your morning routine really says about you – New York Post

What Your Morning Routine Says About Who You Really Are

July 2, 2025
David Muir, Diane Sawyer, Charlie Gibson honor ‘World News Tonight’ stage manager – MSN

David Muir, Diane Sawyer, Charlie Gibson honor ‘World News Tonight’ stage manager – MSN

July 2, 2025
Amid Russian economy warnings, Lavrov says NATO’s increased defense spending will lead to ‘collapse’ of alliance – The Kyiv Independent

Lavrov Warns Soaring NATO Defense Budgets May Spark Alliance Collapse

July 2, 2025
Column: The new book ‘Sick and Dirty’ examines the not-so-hidden queerness of classic Hollywood – Yahoo

Uncovering the Bold Queerness of Classic Hollywood in the New Book ‘Sick and Dirty

July 2, 2025

In Good Health: Vaccines, Menopause, And Cardiovascular Disease : 1A – NPR

July 2, 2025

Categories

Archives

July 2025
MTWTFSS
 123456
78910111213
14151617181920
21222324252627
28293031 
« Jun    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (702)
  • Economy (727)
  • Entertainment (21,615)
  • General (15,670)
  • Health (9,766)
  • Lifestyle (732)
  • News (22,149)
  • People (728)
  • Politics (734)
  • Science (15,945)
  • Sports (21,225)
  • Technology (15,712)
  • World (708)

Recent News

Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

Inspira Technologies Secures Landmark $22.5M Deal: Major Revenue Breakthrough After FDA Clearance – Stock Titan

July 2, 2025
Diamondbacks ban fan who interfered with apparent would-be Giants HR for rest of season, citing ‘multiple offenses’ – Yahoo Sports

Diamondbacks ban fan who interfered with apparent would-be Giants HR for rest of season, citing ‘multiple offenses’ – Yahoo Sports

July 2, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version