- After recalls and infections🔍
- FDA Inspection of Foreign Drug Companies🔍
- Tainted drugs🔍
- Foreign Government Subsidies and FDA Regulatory Failures Are ...🔍
- The FDA's Proposed Ruling on Lab Tests Could Have Unintended ...🔍
- 2024|08935.pdf🔍
- Managing Foreign Supply Chains to Avoid Importing Risk🔍
- FDA struggles to inspect overseas pharmaceutical suppliers🔍
Serious concerns raised over FDA's capacity to inspect overseas ...
After recalls and infections, experts say safer eyedrops will require ...
“The FDA is not getting its job done in terms of drug quality assurance inspections abroad,” said David Ridley of Duke University and co-author ...
FDA Inspection of Foreign Drug Companies - U.S. Pharmacist
Two days before Dr. Woodcock testified at the Senate hearing, her boss, FDA Commissioner Andrew von Eschenbach, MD, told the House Committee on ...
Tainted drugs: Ex-FDA inspector warns of dangers in U.S. meds ...
Massoud Motamed says the FDA struggles to police the sprawling number of overseas drug manufacturers who may hide problems in their production lines.
Foreign Government Subsidies and FDA Regulatory Failures Are ...
The FDA's foreign inspection program, which the Government Accountability Office (GAO) recently described as facing “unique challenges,” is ...
The FDA's Proposed Ruling on Lab Tests Could Have Unintended ...
“The FDA is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test ...
2024-08935.pdf - Federal Register
... posed to patients. Nor does. FDA believe it should gather more information about potential problems with IVDs offered as. LDTs prior to ...
Managing Foreign Supply Chains to Avoid Importing Risk - Medmarc
... foreign suppliers have put the spotlight on FDA's track record for foreign inspections. ... serious strides in its audit and enforcement efforts abroad ...
FDA struggles to inspect overseas pharmaceutical suppliers
Technical problems also persist in how FDA conducts its overseas inspections, the GAO said. 'Unlike domestic inspections, FDA does not arrive ...
FDA's Role in the Medical Product Supply Chain and ... - CRS Reports
Of particular concern for some are the United States' reliance on foreign sources of medical products and the federal government's ability to ...
Too Little, Too Late: Ineffective Regulation of Dietary Supplements in ...
In addition, concerns about the safety of routine and high-dose supplementation have been raised. The Food and Drug Administration regulates dietary ...
Can the FDA Improve Oversight of Foreign Clinical Trials
... Raises Concern Over Foreign Drug Trials,. CBS NEWS. (Jun. 22, 2010), http ... The Trovan studies raised serious concerns about the unethical treatment of.
FDA Warning Letter & Inspection Observation Trends [Updated 2023]
CDER will continue to seek to minimize long-standing problems such as drug shortages due to quality issues through proactive efforts including ...
How the FDA's food division fails to regulate health and safety hazards
A POLITICO investigation based on more than 50 interviews finds the FDA is failing to meet American consumers' expectations on food safety and nutrition.
The letter raises issues of potential bribery, fraud, and institutional weaknesses within the FDA's inspection processes. The committee requests ...
What Is the FDA's Role in Public Health?
Criticisms of the agency center on the extent of its regulatory powers and the risk that FDA officials could be swayed by the powerful ...
FDA's inspections still lag pre-pandemic period
An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing ...
FDA Inspection Shutdown Increasingly Delays Approvals
FDA puts applications on hold as the agency limits alternative oversight methods. ... In March 2020, FDA halted most field inspections of ...
“Evaluating FDA Human Foods and Tobacco Programs” - YouTube
The Committee on Energy and Commerce is the oldest standing legislative committee (established 1795) in the U.S. House of Representatives ...
FDA's Actions in Response to 2019 Novel Coronavirus at Home and ...
For the month of February, the FDA identified all scheduled inspections in China, and they were either postponed or the agency was able to ...
Facility Inspection Backlog Bogs Down FDA - Salus Medical
The FDA has also turned to alternate inspection tools for its foreign drug oversight. They are relying on ex-U.S. regulators, reviewing records, and testing ...