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94 Total results for product and free and sample content found

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.

HBW Insight

Sunscreen Industry Faces Major Challenge In GRASE Push That OTC Monograph Reform Would Solve

By Ryan Nelson 28 Nov 2019

Article

Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.

HBW Insight

Complicated Regulatory Odyssey Steers FDA Toward Rule On CBD In Supplements

By Malcolm Spicer 27 Nov 2019

Article

Before Congress de-scheduled hemp at end of 2018 and forced agency's hand on considering lawful use of ingredients derived from the plant in supplements and food, the floodgate for sales of the products was opened in 2013 by a DoJ policy change to de-emphasize enforcement of most federal marijuana laws.

Medtech Insight

CooperVision Nabs Approval On Pediatric Contact Lens

By Elizabeth Orr 20 Nov 2019

Article

A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.

Topic FDA

Pink Sheet

Zolgensma Data Integrity Fallout

20 Nov 2019

Zolgensma Data Integrity Fallout

Novartis finds itself facing possible criminal or civil action for admitted data manipulation on its application for Zolgensma, a gene therapy used to treat children with spinal muscular atrophy (SMA) – manipulation disclosed only after FDA approval. Pink Sheet was the first to report on the drug’s loss of EU accelerated assessment, nearly 3 weeks before the pharma giant admitted to submitting falsified data to FDA. Follow the scandal and anticipate its implications on the industry with Pink Sheet’s coverage and timeline.

Topic Cell and gene therapy FDA

Pink Sheet

Amarin's Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

By Sue Sutter 13 Nov 2019

Analysis

REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.

Topic Drug review FDA

Medtech Insight

Senators Question FDA's Proposed Progressive Approval Pathway For Devices

By Sue Darcey 13 Nov 2019

Article

US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.

Topic FDA Policy and regulation

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