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Stay up to date and explore the repercussions of the US government partial shutdown, from the effects of interrupted FDA activities, to the ramifications of a cease in operations at the US Patent and Trademark Office, and beyond.
5 Total results for product and free and sample content found
Pink Sheet
Exhaustion of US FDA's PDUFA funds before partial federal government shutdown ends could lead sponsors or agency to assert that reviews for certain types of drugs should continue under an exception to the Anti-Deficiency Act, former FDA officials say.
Topic US Shutdown FDA
Pink Sheet
More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.
Topic US Shutdown FDA
Pink Sheet
As the partial US government shutdown enters its second month, the backlog of device pre-market applications is building. AdvaMed is proposing language that would allow FDA to accept and review new user-fee-funded submissions during government shutdowns.
Topic US Shutdown FDA
Medtech Insight
The recently ended record-setting US government shutdown is not anticipated to have a long-term impact on US FDA device review times. But agency reviewers will face more 510(k) review deadline pressures than usual and may have limited availability for pre-submission meetings in the short term, one expert suggests.
Topic FDA US Shutdown
Pink Sheet
FDA cosmetics operations likely shuttered with shutdown; Stomp leads Kemin's global marketing; Unilever delivers on fragrance transparency pledge; Lentein protein to Canada through CK Ingredients; and Deciem founder Truaxe dead at 40.
Topic US Shutdown FDA
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