Janet Wood­cock may have one of the most his­tor­i­cal­ly long and drug-in­tense tenures in FDA his­to­ry, but her new role is out­side of all things phar­ma and the once-act­ing FDA com­mis­sion­er isn’t look­ing back.

“No I re­al­ly don’t look back,” Wood­cock told End­points News via email on Mon­day morn­ing. “Yes I will be tran­si­tion­ing. Longer dis­cus­sion on in­fra­struc­ture need­ed.”

FDA Com­mis­sion­er Rob Califf an­nounced in a memo to staff last week that Wood­cock would be tran­si­tion­ing away from her work on phar­ma­ceu­ti­cals.

When asked what she’s been tasked with in her new role, she said she’ll be tran­si­tion­ing to a role more fo­cused on in­fra­struc­ture, “al­so al­ter­na­tives to an­i­mal test­ing, com­mu­ni­ty-based clin­i­cal tri­als to im­prove di­ver­si­ty, spe­cif­ic hir­ing ac­tiv­i­ties, re­solv­ing in­ter­nal prob­lems, im­prov­ing hir­ing abil­i­ty, ’24 bud­get for­mu­la­tion, etc.”

Last week, Wood­cock and Mered­ith Chuk, di­rec­tor of FDA’s En­ter­prise Trans­for­ma­tion Op­er­a­tion, penned a blog post on their in­fra­struc­ture mod­ern­iza­tion plans, ex­plain­ing how the FDA “must have more ef­fec­tive and ef­fi­cient busi­ness process­es, in­creased ca­pa­bil­i­ties to bet­ter use the da­ta that we re­view, and a more co­or­di­nat­ed de­vel­op­ment of the IT sys­tems de­signed to sup­port these ac­tiv­i­ties.”

Frank Yian­nas

Fol­low­ing a trip to Cal­i­for­nia late last week, Wood­cock al­so not­ed that she’s been in­un­dat­ed with emails from two cam­paigns, in­clud­ing one on PFAS, which are wide­ly used, long-last­ing chem­i­cals, com­po­nents of which break down very slow­ly over time.

As far as ru­mors that Wood­cock took over as the lead for the in­fant for­mu­la fi­as­co at FDA re­cent­ly, as part of this tran­si­tion, Wood­cock clar­i­fied to End­points that Frank Yian­nas, deputy com­mis­sion­er for FDA’s food pol­i­cy and re­sponse, is the lead for the push to break the log­jam of in­fant for­mu­la short­ages.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.