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27 Total results for product and free and sample content found

Pink Sheet

US FDA's Plan On Right To Try: Big On Congressional Engagement, Short On Policy Details

By Sue Sutter 14 Jun 2018

Internal group headed by Principal Deputy Commissioner Rachel Sherman will develop implementation recommendations, which could include new guidance, regulations, a Q&A document or ‘nothing at all,’ Commissioner Gottlieb tells BIO annual meeting; he promises consultation with the law’s supporters and critics on Capitol Hill ‘to fully understand what the intent was with different provisions.’

Topic FDA

Pink Sheet

FDA Finally Approves Avastin In First-Line Ovarian Cancer

By Emily Hayes 14 Jun 2018

Genentech says it worked closely with the agency to bring the drug to women with earlier-stage disease.

Topic Cancer FDA

Medtech Insight

Conformity And Confidence: US FDA Seeks To Build Trust In PreMarket Standards Declarations

By David Filmore 30 May 2018

FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.

Topic FDA

Medtech Insight

Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination

22 May 2018

While only two devices have received approval and a national coverage determination through US FDA/CMS' parallel review program, a top CMS official says industry needs to look beyond just the numbers. Instead, she says the parallel review program is part of a sea-change that has allowed for better communication between CMS, FDA and sponsors.

Topic FDA

Scrip

FDA Refuse-To-File Letter For Alkermes Depression Drug Suggests A Lengthy Commercial Delay

By Jessica Merrill 15 May 2018

CEO Richard Pops called FDA's letter for ALKS 5461 "surprising and troubling." Alkermes had been ramping up to launch the depression drug later this year, though some investors had remained skeptical.

Topic FDA Drug approval

Pink Sheet

Ex-US FDA Official Sklamberg On Park Doctrine Limits Data Integrity

By Anju Ghangurde 15 May 2018

Courts may increasingly find limits on how far Park Doctrine tool can be ‘pushed,’ Sklamberg says in wide-ranging interview with the Pink Sheet. Former US FDA deputy commissioner for global regulatory operations and policy, now with law firm Akin Gump, also shares his views on the US-EU MRA to recognize each other’s inspections and data integrity.

Topic FDA

Scrip

How Pfizer Warning Letter Tarnished Sandoz/Momenta's Glatopa Launch

By Bowman Cox 23 Feb 2018

An FDA warning letter to a contract manufacturer, Pfizer, delayed Sandoz/Momenta's Glatopa 40 mg launch, reducing projected revenues and leading Momenta to consider selling assets.

Topic FDA Business strategies

Pink Sheet

Drug Sponsors Who Fail To Submit One-Time Report Face Big Penalty

By Derrick Gingery 09 Feb 2018

US FDA could move sponsor's products from active to discontinued section of Orange Book if agency doesn't receive the FDARA-required report by Valentine's Day.

Topic Drug approval Drug review FDA

Pink Sheet

US FDA Approval Climate: What Do The Oral Testosterone Reviews Tell Us?

By Ramsey Baghdadi 27 Jan 2018

Second go-round for oral testosterone could have marked new boundary on how far FDA is willing to go...

Topic FDA

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