- Serious concerns raised over FDA's capacity to inspect overseas ...🔍
- FDA Has Faced Persistent Challenges Overseeing Foreign Drug ...🔍
- FDA inspection backlog overseas threatens new drug approvals🔍
- New report highlights weak FDA oversight of foreign firms making ...🔍
- Shortcomings In The FDA's Foreign Drug Inspection Program ...🔍
- Chair Rodgers Opening Remarks on the Shortcomings in the FDA's ...🔍
- COVID|19 and Beyond🔍
- FDA Global Drug Inspections🔍
Serious concerns raised over FDA's capacity to inspect overseas ...
Serious concerns raised over FDA's capacity to inspect overseas ...
Allegations of attempted coverups abound. In October of 2018, an FDA investigator at Strides Pharma Science Limited in India discovered bags of ...
Serious concerns raised over FDA's capacity to inspect overseas ...
According to the warning letter, made available on the FDA's website, the company told the FDA that the binder had "inadvertently come [sic] to ...
FDA Has Faced Persistent Challenges Overseeing Foreign Drug ...
This testimony discusses our long-standing concerns about the Food and Drug Administration's oversight of the global pharmaceutical supply chain.
FDA inspection backlog overseas threatens new drug approvals
As the rate of overseas inspections remains low, U.S. pharmas have faced delays in drug approvals due to problems with third-party manufacturers ...
New report highlights weak FDA oversight of foreign firms making ...
During this period, the FDA relied on remote inspections, document reviews, and reports from foreign regulators. But by 2022, a backlog had ...
Shortcomings In The FDA's Foreign Drug Inspection Program ...
The Committee on Energy and Commerce is the oldest standing legislative committee (established 1795) in the U.S. House of Representatives ...
Chair Rodgers Opening Remarks on the Shortcomings in the FDA's ...
“I'm concerned that the FDA is failing in its mission. It is not adequately executing its foreign inspection program, which was questionable ...
COVID-19 and Beyond: Oversight of the FDA's Foreign Drug ...
For-cause inspections: Triggered when FDA has reason to believe that a facility has serious manufacturing quality problems or when FDA wants to ...
FDA Global Drug Inspections: Surveillance Of Manufacturing ...
Inspecting foreign facilities has many challenges. The FDA faces jurisdictional issues, language barriers, and travel clearance requirements. To ...
United States: Increasing FDA inspections and enforcement in China
Along with India, China represents one of the two countries with the most foreign drug and device establishments subject to FDA inspection.
FDA has massive backlog of factory inspections as staffers leave for ...
In 2020, the FDA halted most inspections of overseas plants that ship drugs, medical equipment and other goods to the U.S. due to the ...
Oversight of FDA's Foreign Inspection Program - 12/10/2019
If a foreign facility is found to have quality problems serious enough for FDA to classify it as OAI, the Agency can place a facility on ...
Drug Safety: Preliminary Findings Indicate Persistent Challenges ...
Further, FDA continues to rely on translators provided by the foreign establishments being inspected, which investigators said can raise ...
Government Accounting Office Questions Ability of FDA to Inspect ...
A recent GAO study raises serious questions about FDA oversight of foreign drug manufacturers ... raises credibility concerns; Advance ...
Subcommittee Chair Griffith Opening Remarks on the Shortcomings ...
Subcommittee Chair Griffith Opening Remarks on the Shortcomings in the FDA's Foreign Drug Inspection Program · LACK OF INFORMATION ABOUT FOREIGN ...
House Committee Hearing Discusses FDA's Shortcomings, Priorities ...
The Food and Drug Administration's (FDA) foreign inspection program was heavily criticized in a House Energy and Commerce Subcommittee ...
Review of the Food and Drug Administration's Foreign Drug ...
Recently, Congress raised concerns about the safety of certain drugs manufactured overseas and the challenges that FDA faces with its foreign drug inspection ...
Grassley presses FDA for more information about foreign ...
In December, officials from the Food and Drug Administration (FDA/Agency) briefed my staff regarding FDA's program for inspecting foreign pharmaceutical ...
The FDA's Weak Drug Manufacturing Oversight is a Potentially ...
The gap between foreign and domestic inspections has widened over the course of the COVID-19 pandemic. Because international travel shut down ...
OVERSIGHT OF FDA'S FOREIGN INSPECTION PROGRAM - GovInfo
Past GAO reports and investigative reporting have raised concerns about the ability of FDA to oversee a globalized supply chain when 80 percent of inspections ...