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Medtech Insight

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

By David Filmore 01 Feb 2019

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

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

28 Jan 2019

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

Pink Sheet

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

By Sue Sutter 28 Jan 2019

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

US FDA Shuttering More Operations As User Fee Money Dwindles

By Derrick Gingery 28 Jan 2019

Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.

Topic US Shutdown FDA

Pink Sheet

FDA's Post-Shutdown ANDA Bolus Could Be Massive

By Derrick Gingery 28 Jan 2019

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

AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

By Ferdous Al-Faruque 28 Jan 2019

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

Standards, Not Predicates Emphasized In Finalized Alternative 510(k) Pathway

By Elizabeth Orr 23 Jan 2019

Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons.

Topic FDA

Pink Sheet

Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers

By Michael Cipriano 16 Jan 2019

FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.

Topic FDA

Medtech Insight

About Three Months Worth Of Carryover Device Fees Remaining FDAs Gottlieb Says

By David Filmore 16 Jan 2019

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

Topic FDA

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