Equipment Lifecycle Management in the Eyes of the FDA The October 2025 Warning Letter to Apotex Inc. is fascinating not because it reveals anything novel about FDA expectations, but because it exposes the chasm between what we know we should do and what we actually allow to happen on our watch.…

So they traveled business class? Seriously this is the last thing I am worried about at the fda. I was just thrilled they showed up.

To combat bird flu spread, other countries have authorized poultry vaccines, but the U.S. has held off amid political and economic opposition. Read our full investigation:

📽️ WATCH: After a bird flu outbreak tore through Midwestern barns, which led to 18 million hens being killed and a spike in egg prices, the Department of Agriculture didn’t investigate whether the virus was airborne. But ProPublica did. @natlash.bsky.social breaks it down: propub.li/4iVcYfD

Horrified to see this tragic news of multiple people shot at my alma mater Brown University. Prayers for everyone harmed in this heinous attack. www.nytimes.com/live/2025/12...

this is a general warrant and it's specifically the kind of warrant the framers passed the 4th amendment to outlaw

I feel deeply betrayed by my senator @warren.senate.gov

Just heard disappointing news that @warren.senate.gov will co-sponsor the Kids Online Safety Act again despite overwhelming opposition from LGBTQ, human rights, abortion rights, and racial justice groups. This is a horrific betrayal of her constituents, particularly trans youth and their families.

Sure. Start here: www.vice.com/en/article/e... then here: www.bostonglobe.com/2025/05/29/o... here: www.transparentsletter.com academic study: citap.pubpub.org/pub/cosl/rel... letter from MA-based LGBTQ orgs delivered to Warren last month: www.fightforthefuture.org/news/2025-09...

The best reading of this article: Trump is going to use FDA to restrict medication abortion, but he wants to wait until after the midterms so the Republicans don't experience blowback. But that just makes the midterms more important. www.bloomberg.com/news/article...

They're using the confinement box, one of the most horrific methods of CIA torture in the post-9/11 black sites, against migrants now. This is the direct result of the lack of consequences for the architects of the torture program. Either there will be criminal penalties for this or it will expand.

❗Join us for a collection showing with some of the LMEC’s oldest city maps❗ This free showing will be hosted Friday, December 12 in the Learning Center with a staff member from the Leventhal Center available to answer questions. Drop in any time between 2:00PM - 4:00PM. No reservation is required.

Our longest episode ever on the theater at the FDA and why we should be very skeptical that antivaxx disinformation doctors suddenly “discovered” the vaccine killed 10 kids. @wendyorent.bsky.social podcasts.apple.com/us/podcast/w...

When the House and Senate marked up stablecoin legislation, we raised all of these concerns - their anonymity, their nearly perfect design for money laundering. All the barn doors were left wide open. It’s used for crime because that is its purpose. www.nytimes.com/2025/12/07/t...

Happy 76th Birthday, Tom Waits!

For my latest @opinion.bloomberg.com, I wrote about this week's ACIP meeting-- yes, the CDC panel's terrible hep B vaccine decision, but the simple strategy RFK's handpicked members are using to sow confusion and distrust in vaccines. (🎁 link)

THREAD: It was supposed to be a routine surgery. So when the doctor stepped out, Sandra Parker wasn’t sure she heard right. Her husband’s heart couldn’t have stopped for more than 5 or 6 minutes, the doctor was saying. “That’s not a lot of time,” Mrs. Parker thought. “Is it?”

Deep sea mining is very bad for deep sea ecosystems.

Yule log dates back to pre-Christian Europe,as part of the ancient winter solstice celebrations.The word "Yule" itself comes from Old Norse word "Jól," referring to pagan festival celebrating the rebirth of sun during the winter solstice. jackandbeyond.com/blogs/cake-r... #FolkloreSunday

Wait, I was told 19 kids dead in a single month didn’t matter.

Prasad says FDA will state that "COVID-19 vaccines have killed American children," which he calls a "profound revelation." He directs FDA staff who disagree to resign. He offers no research data & doesn't submit it to peer review. Science is transparent, it is testable. This is not science

Oh my goodness gorgeous! Now I want a set of bias cookies.

Transcendence experience Thursday night. The artist and musician Lonnie Holley performed at The Wallis with Moor Mother after losing his oldest sister, Betty, the day before.

I try to be as measured as possible on social media, but everyone in the art world—including art historians!—who in recent years has focused incessantly on "the contemporary" is at fault for developments like this. This is what happens when you fail to value history hyperallergic.com/1058320/why-...

Pottery finish! Two small cocottes/crocks/tapas serving dishes (oven-safe terracotta pots with lids)! I made the taller, narrower one, and @jeremiahgenest.bsky.social made the wider, shallower one.

"In 2025, 40% of women aged 15 to 44 say they would move abroad permanently if they had the opportunity. The current figure is four times higher than the 10% who shared this desire in 2014, when it was generally in line with other age and gender groups."

As of this morning, Starbucks workers across the country are officially ON STRIKE. And we're prepared for this to become the biggest and longest ULP strike in Starbucks history. Say #NoContractNoCoffee with us: DON'T BUY STARBUCKS for the duration of our open-ended ULP strike! $SBUX

USP Revised: Aligning Compendial Validation with ICH Q2(R2) and Q14’s Lifecycle Vision The United States Pharmacopeia's proposed revision of General Chapter  Validation of Compendial Procedures, published in Pharmacopeial Forum 51(6), represents the continuation of a fundamental shift in how…

Quality: Think Differently – A World Quality Week 2025 Reflection As we celebrate World Quality Week 2025 (November 10-14), I find myself reflecting on this year's powerful theme: "Quality: think differently." The Chartered Quality Institute's call to challenge traditional approaches and embrace…

Dekker is also tremendously influential on the site reliability engineering discipline. And Jere’s blog is always worth reading if you’re a tech geek; surprising how much overlap there is between pharma quality and keeping servers running.

Sidney Dekker: The Safety Scientist Who Influences How I Think About Quality Over the past decades, as I've grown and now led quality organizations in biotechnology, I've encountered many thinkers who've shaped my approach to investigation and risk management. But few have fundamentally altered my…

New map compiled by archaeologists charts twice as many Roman roads as the standard reference work. Their sources include ancient travel itineraries, 19thC camel routes, Soviet military charts, Ottoman surveys and declassified American spy-satellite images. www.thetimes.com/article/335a...

"None of the proposals outlined by Makary and Prasad justify firing hundreds of scientific experts dedicated to protecting public health. Staffing and budget cuts will only further diminish the FDA’s capacity to approve drugs in a timely manner." jamanetwork.com/journals/jam... True words

More disruption at #FDA. Exclusive from @lizzylawrence.bsky.social and @adamfeuerstein.bsky.social. www.statnews.com/2025/11/02/f...

I’ve stopped business travel for the time being.

And now it’s time for our annual viewing of The Haunting (1963): my favorite horror movie, and probably the best haunted house movie of all time

We live in a condo, and rarely get trick-or-treaters, so today we set up a table outside, actually handed out some candy, and got to say hi to some of our neighbors. We also had some anti-ice/know your rights pamphlets to hand out.

Food banks have already been well past capacity since the start of 2025. The infrastructure we have absolutely cannot support the enormous number of people who are about to lose access. Please if you can, find your local food bank and give today.

If you're looking for some food banks to donate to, we vetted a ton all over the country back in 2020, in conjunction with our marble league sponsorship, a sentence that I swear made sense in context. Anyway -- there are links to 17 of them in this thread. (And apologies for linking to... y'know.)

Or, and radical thought here, we can trust when someone tells us who they are. I know a deeply personal choice for most people. So I always trust what someone’s tattoos tell me. And nazi symbols tells me everything I need to know to want to be far away

If he was a “convert” the tattoo would have been removed. And seriously why do I need to forgive former Nazi’s? Let him spend his life in humble service if he’s contrite and not run for one of the highest offices.

Chris Murphy admits he’s fine with Nazi sympathizers. I clearly understand his current behavior towards the current regime.

We have a great opportunity to vote against Seth Moulton AND to support a primary challenge against him. bethfordemocracy.com

Just watched Strange Harvest (2025) which I found disappointing. Great adherence to the format of a true crime documentary but it was unable to thread the Lovecraftian needle.

Hey all, food insecurity is expected to rise dramatically this fall & winter. I’ve just set up monthly donations with my local food banks (that’s GBFB and Project Bread here in Boston), and you can, too! Or make a one-time donation if that works better for you (money is better than goods)!

I agonized for 4 years over 1 tattoo making sure it was right for me. I think I can at minimum expect a senate candidate to fully understand the symbolism of ink on his body

Material Tracking Models in Continuous Manufacturing: Development, Validation, and Lifecycle Management Continuous manufacturing represents one of the most significant paradigm shifts in pharmaceutical production since the adoption of Good Manufacturing Practices. Unlike traditional batch…

One of many reasons why Bernie is a problem and should retire. www.independent.co.uk/news/world/a...