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37 Total results for product and free and sample content found


Amicus' Oral Fabry Drug Priced To Compete Against Traditional ERT

By Jessica Merrill 17 Aug 2018

FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.

Topic FDA

Medtech Insight

QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like

By Shawn M. Schmitt 17 Aug 2018

US FDA will face high hurdles as it works to write a new rule that would merge the agency's Quality System Regulation with international quality systems standard ISO 13485. That's according to Kim Trautman, a longtime industry insider who wrote the QSR in the early to mid-1990s. "It’s a clear heavy lift from a regulatory policy perspective" that could take as long as five years to complete, she says. In the meantime, Trautman offers some insight into what device-makers might see in a new hybrid quality systems regulation from FDA. She addresses everything from corrective and preventive action (CAPA) to labeling, and complaint handling to risk management – and more.

Topic FDA

Medtech Insight

Pre-Certs, Test Groups And More: US FDA Outlines Possible New Dx Paradigm

By Sue Darcey 17 Aug 2018

The agency has responded to a draft diagnostics reform bill in Congress with proposed reforms that diverge some ways from the proposed legislation, but stick with the underlying goal of completely remaking how lab tests, including test kits and lab-developed tests, are regulated. The agency has put forward a proposal to establish a pre-certification process for test developers, divide most tests into high- or low-risk categories (but exempt many from pre-market review) and remove the concept of substantial equivalence.

Topic FDA

Pink Sheet

US FDA’s Breakthrough And RMAT Designations: A Quick Guide

By Bridget Silverman 14 Aug 2018

Differences in eligibility and evidentiary criteria between the US FDA's two expedited regulatory programs are reflected in a new guide; metrics to date suggest comparable success rates for designation requests under the two programs. Our infographics aid in understanding the programs.

Topic FDA

Pink Sheet

US FDA's Regulatory Flexibility To Be Tested As Delcath Overhauls Melphalan Trial Design

By Sue Sutter 30 Jul 2018

Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.

Topic Clinical trials Drug approval Rare Disease FDA

Pink Sheet

Sarepta Learns Why Earlier GMP Control Is Better For Promising Gene Therapies

By Bowman Cox 30 Jul 2018

When firms are developing highly anticipated gene therapies, it’s important to establish GMP-controlled manufacturing processes earlier in development, as Sarepta discovered when US FDA placed a clinical hold on a promising Duchenne muscular dystrophy gene therapy.

Topic FDA

Rose Sheet

FDA Analysis Of Non-Traditionally Preserved Cosmetics Indicates Likely Contamination Source

By Ryan Nelson 24 Jul 2018

The agency’s survey of eye-area cosmetics marketed as free of traditional preservatives doesn’t raise any obvious red flags. However, it does point to a possible contamination source and suggests “the limits of preservative activity in cosmetics.”

Topic FDA

Medtech Insight

Pathogen-Reduction Tech Gets Some Focus At FDA Panel Meeting, But Not Enough, Cerus Says

By Ferdous Al-Faruque 24 Jul 2018

While a panel of US FDA experts agreed pathogen reduction technology is a promising strategy for reducing blood platelet contaminations, they raised concerns about the cost of implementing the technology. The maker of the technology, Cerus, says the panel was under-briefed and distracted.

Topic FDA Policy and regulation

Pink Sheet

US FDA's Rare Diseases Program Not Expected To Change With Drug Office Reorg

By Derrick Gingery 28 Jun 2018

Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.

Topic FDA

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