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44 Total results for product and free and sample content found

Medtech Insight

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

By Shawn M. Schmitt 12 Sep 2018

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

Topic FDA

Medtech Insight

'Quik' Review Program Builds On US FDA eSubmission Efforts

By David Filmore 06 Sep 2018

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

Topic FDA

Scrip

Shire Could Reclaim HAE Prophylaxis Market From CSL Behring

By Joseph Haas 30 Aug 2018

Offering better efficacy than Shire’s existing HAE therapies and dosing convenience compared to CSL Behring’s prophylactic Haegarda, the specialty pharma may take back market share lost to its competitor and consolidate its leadership in the space.

Topic FDA

Pink Sheet

US FDA To Withdraw Pain Drug Guidance As Part Of Response To Opioid Epidemic

By Nielsen Hobbs 30 Aug 2018

"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."

Topic FDA

Medtech Insight

Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

By Ferdous Al-Faruque 30 Aug 2018

AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.

Topic FDA Medtech

Rose Sheet

Toxicity Testing For Topical Drugs, Sunscreens Included, On Tap In US FDA Workshop

By Ryan Nelson 23 Aug 2018

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.

Topic FDA

Medtech Insight

TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance

By Reed Miller 23 Aug 2018

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties – and it looks like SMEs will be hardest hit.

Topic FDA

Pink Sheet

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

By Sue Sutter 22 Aug 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

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

By Derrick Gingery 22 Aug 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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