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60 Total results for product and free and sample content found

FDA Consumer Health Market Oversight Stays In Spotlight In Gottlieb's Final Week

By Malcolm Spicer 11 Apr 2019

In four days before Scott Gottlieb's stint as commissioner ended, FDA announced official start of initiative to consider regulatory pathways to make CBD compliant as a dietary ingredient, launched another shot across kratom sector's bow and noted more examples of e-cigarette marketers crossing regulatory lines.

Topic fda

With High Profile At FDA, Gottlieb Headed Ambitious Consumer Health Initiatives

07 Mar 2019

Scott Gottlieb claimed higher profile than most previous FDA commissioners with frequent Twitter posts and by including his remarks in many agency communications to industries and consumers. In his nearly two years in post, he also had more central role in FDA initiatives in areas such as keeping unsafe products labeled as supplements off the market and explaining why hemp and CBD are available and supplements even though FDA considers the products noncompliant as dietary ingredients.

Topic 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

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: 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

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: 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 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: 世界の薬事規制と承認審査に関するニュース

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: 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

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: 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 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

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