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Biomedtracker, Datamonitor Healthcare

2020 Early Outlook Webinar

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

Pink Sheet

For Coronavirus US FDA Is At The Podium But Not On The Task Force

Hahn speaks at Coronavirus briefing

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic FDA Vaccines Infectious Diseases Coronavirus

Medtech Insight

QUOTED. 24 January 2020. Megan McSeveney.

Quoted_24_January_2020

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Topic Drug approval Coronovirus FDA

HBW Insight

OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

OTC_Drug_Oversight_By_US

CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

Pink Sheet

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

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 and regulation

Medtech Insight

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 1)

Compliance_Corner_Part_1

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.

Medtech Insight

Exec Chat: CES 2020: For FDA's Amy Abernethy It's About Data, But Also Community Engagement

Exec_Chat_CES_2020

Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.

Topic Digital Health FDA

Medtech Insight

FDA Will Keep Listening To Patient-Engagement Experts

FDA_Will_Keep_Listening

The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.

HBW Insight

'Supplement' on CBD Product Label A Bullseye For US Litigants, Says Attorney

Supplement_On_CBD_Product_Label_A_Bullseye_1

Two CBD marketers warned by FDA in a recent crackdown are targeted in class action complaints alleging they made unsubstantiated health claims and mislabeled ‘illegal drug’ products as supplements. Complaints are a wake-up call to CBD wellness industry to ensure claims are substantiated, as the class action bar is on the prowl following the agency’s 15 warning letter blast in November.

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