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Pink Sheet

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

By Brenda Sandburg 16 Jan 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 and regulation

Medtech Insight

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

By Shawn M. Schmitt 15 Jan 2020

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

By Marion Webb 15 Jan 2020

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

By Ferdous Al-Faruque 08 Jan 2020

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

By Eileen Francis 18 Dec 2019

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.

Medtech Insight

FDA Proposes End To Quarterly Reporting On HDE, PMA Decisions

By Elizabeth Orr 18 Dec 2019

FDA_Proposes_End_To_Quarterly_Reporting

A proposal from the US FDA would end quarterly publication of PMA and Humanitarian Device Exemption verdicts in the Federal Register. The agency says the practice is inefficient and duplicates online publication.

HBW Insight

US Senate Passes First Monograph Reform Bill After House Passed Three

By Malcolm Spicer 11 Dec 2019

Article

Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.

HBW Insight

Future of CBD In Supplements: NDI Notification Looms As Regulatory Path

By Malcolm Spicer 06 Dec 2019

Article

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

Pink Sheet

Former FDA Commissioner Frank Young Passes Away At 88

By Michael Cipriano 28 Nov 2019

Article

From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.

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