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5 Total results for product and free and sample content found

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Shutdown Will Drug Reviews Become Emergencies When User Fee Money Runs Out

By Sue Sutter 02 Jul 2019

Shutdown Will Drug Reviews Become Emergencies When User Fee Money Runs Out

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: 世界の薬事規制と承認審査に関するニュース

FDA's Post-Shutdown ANDA Bolus Could Be Massive

By Derrick Gingery 02 Jul 2019

FDA's Post-Shutdown ANDA Bolus Could Be Massive

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: 世界の薬事規制と承認審査に関するニュース

AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

By ferdous-al-faruque 15 Jun 2019

AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

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: 世界の医療機器・医療技術の最新情報

Bumps In The Road As US FDA Tries To Catch Up From Shutdown

11 Jun 2019

Bumps In The Road As US FDA Tries To Catch Up From Shutdown

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: 世界の薬事規制と承認審査に関するニュース

Health, Beauty And Wellness News: FDA Shutdown, Kemin Marketing VP, More

28 Jan 2019

Health, Beauty And Wellness News: FDA Shutdown, Kemin Marketing VP, More

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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