skip to main content
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.
Global Search Configuration

Refine Results

Clear All

Specialism

Show More

Resources

Show More

Products

Show More

Show More

71 Total results for product and free and sample content found

Pink Sheet

US FDA's COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

By Nielsen Hobbs 29 Nov 2020

FDA Miss Deadline

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Topic Coronavirus FDA

Medtech Insight

FDA Boosts Development Of OTC COVID-19 Tests With New Template

By Elizabeth Orr 27 Nov 2020

FDA Boosts Development Of OTC COVID-19 Tests With New Template

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Topic Coronavirus FDA Diagnostics

Medtech Insight

COVID-19: CDRH Staff Leaves Door Open For Some LDT Safety Oversight

By Elizabeth Orr 27 Nov 2020

Medtech Coronavirus test tubes

US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.

Topic Coronavirus FDA

Generics Bulletin

Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

By Penelope MacRae 27 Nov 2020

Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.

Topic FDA Diabetes BioPharmaceutical

Pink Sheet

A Visual Guide To US FDA's Evolutionary Decade In Review

By Brenda Sandburg 27 Nov 2020

FDAs_Evolutionary_Decade_In_Review

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

Topic FDA Policy & Regulation

Pink Sheet

Biden's COVID-19 Advisory Board Bodes Well For Science-Driven FDA

By Sarah Karlin-Smith 18 Nov 2020

Biden Kamala Covid19 advisory board

Two prominent former US FDA officials are a part of the president-elect’s new COVID-19 advisory board. Biden’s emphasis on scientific independence, including a commitment to publicly release vaccine trial data, could help restore public confidence in the agency and coming COVID-19 vaccines.

Topic US Election 2020 Coronavirus FDA

Pink Sheet

What Did US FDA Do Wrong In Its Review Of Aducanumab AdCom Members Have A List

By Brenda Sandburg 17 Nov 2020

FDA Advisory Committee

Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.

Topic advisory committees Drug Review FDA

Pink Sheet

What Justice Ginsburg's Death Means For Pharma

By Nielsen Hobbs 22 Sep 2020

Supreme Court Washington

A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.

Topic US Election 2020 FDA

Biomedtracker, Datamonitor Healthcare

2020 Early Outlook Webinar

By Michael ​ Haydock 28 Feb 2020

Anticipate the biggest, most impactful expected catalysts of early 2020 with the guidance and insights from Pharma Intelligence. Building off Biomedtracker’s Early 2020 Outlook report, our live webinar will include market context for these upcoming milestones and additional insights from Datamonitor Healthcare’s Therapeutic Area Directors.

Topic FDA

Next steps

Getting a demo tailored to your needs is the best way to see how our solutions will help you gain an advantage.

Request live demo now:

Our team is ready to hear from you for a particular request or area of interest. Please do not hesitate to reach out and discuss.

Contact us for product technical and account support.

  • US Toll-Free   : +1 888 670 8900 
  • US Toll             : +1 212-600-3520
  • UK & Europe : +44 (0) 208 052 0700

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now: