- New report highlights weak FDA oversight of foreign firms making ...🔍
- FDA is failing to inspect drug and device makers🔍
- Resilient Drug Supply🔍
- FDA Has Faced Persistent Challenges Overseeing Foreign Drug ...🔍
- FDA Reports Quality Lapses At Indiana Drug Factory That Novo Is ...🔍
- FDA Global Drug Inspections🔍
- FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection ...🔍
- The Food and Drug Administration's Foreign For|Cause Drug ...🔍
New report highlights weak FDA oversight of foreign firms making ...
New report highlights weak FDA oversight of foreign firms making ...
New report highlights weak FDA oversight of foreign firms making medications for US market ... "We have identified long-standing weaknesses in ...
FDA is failing to inspect drug and device makers, government ...
The US Food and Drug Administration has not met its legal requirements to inspect US and foreign medical drug and device manufacturers, and it has not ...
Resilient Drug Supply | CIDRAP - University of Minnesota
HHS report highlights steps to mitigate drug shortages ... New report highlights weak FDA oversight of foreign firms making medications for US market.
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 ...
FDA Reports Quality Lapses At Indiana Drug Factory That Novo Is ...
Reuters: US FDA Finds Control Lapses At Catalent Plant Being Sold To Novo · CIDRAP: New Report Highlights Weak FDA Oversight Of Foreign Firms ...
FDA Global Drug Inspections: Surveillance Of Manufacturing ...
Indeed, the FDA Office of Regulatory Affairs uses a combination of US-based and foreign staff to inspect establishments outside the US.
FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection ...
Sponsors conducting clinical research exclusively in foreign countries are not required to submit an investigational new drug application to FDA ...
The Food and Drug Administration's Foreign For-Cause Drug ...
FDA reported that 74 percent of active pharmaceutical ingredient manufacturers and 54 percent of finished goods manufacturers are located ...
to require animal drug sponsors to make safety-related labeling changes based on new ... Additionally, FDA seeks new authority to require firms that manufacture ...
OVERSIGHT OF FDA'S FOREIGN INSPECTION PROGRAM - GovInfo
... reports on the results of its recent travel overseas ... FDA's resources to conduct foreign inspections and granted FDA new authorities over foreign firms.
FDA Warning Letter & Inspection Observation Trends [Updated 2023]
FDA Warning Letter & Inspection Trend Highlights: 2023 · In FY2022, FDA issued 62 warning letters and 23 import alerts related to drugs, ...
In Wake of New Report Showing Dangerous Gap in Drug Safety ...
“When drug companies outsource pharmaceutical ingredients, they also outsource drug safety standards,” Brown said. “It's simply unacceptable to ...
Oversight of FDA's Foreign Inspection Program - 12/10/2019
With new resources, FDA has been able to inspect some facilities that previously had not been inspected. CDER's Catalog showed that as of July ...
Hearing Highlights Foreign Drug Manufacturing Oversight ...
In a recent hearing before the House Subcommittee on Oversight and Investigations, a Government Accountability Office official reiterated the challenges ...
FSMA Final Rule on Produce Safety - FDA
FDA has released for public comment its proposed rule to establish science-based standards for growing, harvesting, packing and holding produce on domestic ...
FDA Regulation of Medical Devices - CRS Reports
Medical devices are an important part of health care service delivery, and developments in new technologies can improve their ability to ...
When selecting specific regulatory tools, FDA works closely with manufacturers and chooses tools that are appropriate to the specific situation. FDA also makes ...
FDA'S FOREIGN DRUG INSPECTION PROGRAM - GovInfo
... regulatory oversight to firms. Mr ... I resigned my most recent FDA position as Regulatory ... oversight of the foreign supply just does not make sense.
Financial Disclosures by Clinical Investigators - FDA
Only the question of ownership of equity in the sponsor of the covered study requires disclosure by the clinical investigator. With regard to comments about ...
House Committee on Energy and Commerce
In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their ...