Elizabeth Orr | Pharma Intelligence

Close Icon We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. By continuing to use the website, you consent to our use of cookies.

ファーマインテリジェンスはInforma PLCのインフォーマインテリジェンス部門の一部です

This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Products:

プレミアムニュース（有料購読）

データベース（有料）

コンサルティング

医薬品開発＆販売コンサルティング

Conferences 2021

アワード

ウェビナー最新情報

ウェビナー録音

Close Icon

お問い合わせフォーム

Close Icon

Global Search Configuration

サイト内検索製品＆サービス検索
Close Icon

Search by Keyword

Focus
Needs

About

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated

Topic Vaccines Coronavirus Distribution

View article
Pink Sheet: 世界の薬事規制と承認審査に関するニュース

US FDA Expects COVID-19 Vaccines To Meet 'EUA Plus' Standards, Marks Says

CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.

Topic Coronavirus vaccines

View article
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

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

View article
Pink Sheet: 世界の薬事規制と承認審査に関するニュース

US FDA May Create Immunology, Neuroscience Centers Of Excellence

Commissioner Gottlieb says new centers would follow template of Oncology Center of Excellence.

Topic fda

article
Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching

Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.

Topic biosimilars

article
Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Rare Diseases: Growing Understanding Will Unlock Accelerated Approval, FDA Says

US FDA officials say they need knowledge of the disease to have the confidence to use accelerated approval.

article
Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Mylan, Amgen Biosimilars Sail Through Advisory Panels, May Diverge From There

Mylan's Herceptin biosimilar faces questions on off-label use and manufacturing.

Topic Biosimilars

View article
Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Voucher Abuse Solution May Stumble On FDA Effects

House bill that would require new clinical studies from sponsor for tropical disease priority review vouchers met with industry concerns about limiting the US agency's flexibility.

Topic Drug approval Drug review Clinical trials

article
Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Cures Bill Authorizes 'Intercenter Institutes,' But Will US FDA Create Them?

Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.

Topic drug-review

article

医薬品ニュースサービス・ヘッドライン from Derrick

世界の薬事規制動向＆情報を配信

02 Mar 2021

Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval

Link
世界の薬事規制動向＆情報を配信

19 Feb 2021

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

Link
世界の薬事規制動向＆情報を配信

16 Feb 2021

US FDA Could Be Facing Bolus Of Pandemic-Related Applications

Link
Generics Bulletin: ジ...

11 Feb 2021

Complex Generics: US FDA, Sponsors View Roadblocks Very Differently

Link
世界の薬事規制動向＆情報を配信

02 Feb 2021

US FDA Vaccines Adcomm May Be Called To Review COVID-19 Vaccine Strain Changes

Link
世界の薬事規制動向＆情報を配信

01 Feb 2021

BsUFA Suggestions From Sponsors Sound Easy, But Changes May Be Difficult For US FDA

Link
世界の薬事規制動向＆情報を配信

29 Jan 2021

Pink Sheet Podcast: COVID-19 Vaccine Dose-Sparing, New Viral Variants, CMS and FDA Leader Updates

Link
世界の薬事規制動向＆情報を配信

19 Jan 2021

ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19

Link
Medtech Insight: 世界の...

15 Jan 2021

Biden COVID-19 Plan Would Grow Domestic Manufacturing Base

Link
Pink Sheet: 世界の薬事規制と...

12 Jan 2021

Adolescent Recruitment For COVID-19 Vaccine Trials Is Worry For Operation Warp Speed

Link
Pink Sheet: 世界の薬事規制と...

08 Jan 2021

Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule

Link
Pink Sheet: 世界の薬事規制と...

22 Dec 2020

FY 2021 Appropriations Provides FDA Healthy Boost – Plus More COVID-19 Funds

Link
Pink Sheet: 世界の薬事規制と...

21 Dec 2020

Expanded Distribution For COVID Vaccines Will Boost Options – And Logistical Complications

Link
Pink Sheet: 世界の薬事規制と...

20 Dec 2020

COVID-19 Vaccine Race: With Moderna EUA, US FDA Finally Gets Some Bragging Rights

Link
Pink Sheet: 世界の薬事規制と...

10 Dec 2020

Pfizer Doesn’t Like Crossover Design For Placebo Patients In COVID-19 Vaccine Trial

Link

About

Analyst Articles

Articles by Derrick

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

US FDA Expects COVID-19 Vaccines To Meet 'EUA Plus' Standards, Marks Says

FDA's Post-Shutdown ANDA Bolus Could Be Massive

US FDA May Create Immunology, Neuroscience Centers Of Excellence

Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching

Rare Diseases: Growing Understanding Will Unlock Accelerated Approval, FDA Says

Mylan, Amgen Biosimilars Sail Through Advisory Panels, May Diverge From There

Voucher Abuse Solution May Stumble On FDA Effects

Cures Bill Authorizes 'Intercenter Institutes,' But Will US FDA Create Them?

医薬品ニュースサービス・ヘッドライン from Derrick

Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

US FDA Could Be Facing Bolus Of Pandemic-Related Applications

Complex Generics: US FDA, Sponsors View Roadblocks Very Differently

US FDA Vaccines Adcomm May Be Called To Review COVID-19 Vaccine Strain Changes

BsUFA Suggestions From Sponsors Sound Easy, But Changes May Be Difficult For US FDA

Pink Sheet Podcast: COVID-19 Vaccine Dose-Sparing, New Viral Variants, CMS and FDA Leader Updates

ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19

Biden COVID-19 Plan Would Grow Domestic Manufacturing Base

Adolescent Recruitment For COVID-19 Vaccine Trials Is Worry For Operation Warp Speed

Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule

FY 2021 Appropriations Provides FDA Healthy Boost – Plus More COVID-19 Funds

Expanded Distribution For COVID Vaccines Will Boost Options – And Logistical Complications

COVID-19 Vaccine Race: With Moderna EUA, US FDA Finally Gets Some Bragging Rights

Pfizer Doesn’t Like Crossover Design For Placebo Patients In COVID-19 Vaccine Trial