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75 Total results for product and free and sample content found

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An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

By Mandy Jackson 15 Aug 2019

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Topic FDA Drug approval

Pink Sheet

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

By Derrick Gingery 14 Aug 2019

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

Topic FDA Company analysis

Medtech Insight

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

By Shawn M. Schmitt 14 Aug 2019

Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.

Topic FDA

Medtech Insight

US and EU Guidance Report

06 Aug 2019

US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.

Topic FDA Digital Health Medtech

Medtech Insight

One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

By Ferdous Al-Faruque 26 Jul 2019

In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.

Topic FDA Policy and regulation

Generics Bulletin

Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

By Penelope MacRae 12 Jul 2019

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

Medtech Insight

Innovator Spotlight: Innovation Through Partnerships Is In Omron Healthcare's Blood

By Marion Webb 12 Jul 2019

This year, Omron Healthcare launched its new HeartGuide smartwatch and the first FDA-cleared blood pressure monitor with EKG capability. Medtech Insight sat down with Omron's CEO Ranndy Kellogg to learn about upcoming plans.

Topic FDA Digital Health

Medtech Insight

Catching Fire: FDA's Manufacturing Maturity Program For Devices Spreading Internationally – And To Drug Facilities

By Shawn M. Schmitt 12 Jul 2019

The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.

Topic FDA Policy and regulation

Generics Bulletin

Strides’ Puducherry Plant Gets FDA Warning Letter

By Penelope MacRae 05 Jul 2019

India’s Strides has received a warning letter from the US Food and Drug Administration over compliance issues at its Puducherry plant. However, the firm has told investors the regulatory action will not affect its forecast of 20% US sales growth for this financial year.

Topic FDA Policy and regulation

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