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Home » Keywords » inspections

Items Tagged with 'inspections'

ARTICLES

Stolen Schedule III study drug leads to US FDA scolding

May 7, 2024
By Mari Serebrov
The theft of 110 units of a study drug containing a Schedule III controlled substance resulted in a warning letter from the U.S. FDA. Addressed to the clinical investigator, Kevin Bender, of the Tamarac, Fla.-based DBC Research Corp., the May 2 letter should serve as a reminder to all trial investigators handling controlled substances.
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Magnifying glass, FDA concept image

US FDA struggling to keep up with clinical research inspections

April 4, 2024
By Mari Serebrov
The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products.
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2023 FDLI Enforcement Conference

Post-pandemic inspection load an ongoing struggle for FDA

Dec. 7, 2023
By Mark McCarty
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
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Toy bulldozer moving FDA letter blocks
2023 FDLI Enforcement Conference

Post-pandemic inspection load an ongoing struggle for FDA

Dec. 6, 2023
By Mark McCarty
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
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US, Switzerland on path to share GMP inspection findings

Jan. 17, 2023
After years of negotiations, the U.S. FDA and Swissmedic are one step away from recognizing each other’s good manufacturing practice (GMP) inspections of biopharma facilities.
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FDA reissues inspection interference guidance to include device manufacturing facilities

Dec. 20, 2022
By Mark McCarty
The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance.
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FDA reissues inspection interference guidance to include device manufacturing facilities

Dec. 15, 2022
By Mark McCarty
The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance.
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No entry sign, white on red backgound

China bans GSK from participating in volume-based tenders following failed GMP inspection

Nov. 1, 2022
By Tamra Sami
Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China.
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US drug codes due for an update

July 25, 2022
By Mari Serebrov
It was bound to happen someday. With more and more prescription drugs coming to the U.S. market, the FDA is running out of unique combinations for the 10-digit national drug code given to each product.
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US health agencies told go back to their offices

June 16, 2022
By Mari Serebrov
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
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