The Pharma Data

MAY 13, 2021

Supplements…” Ray Cowie still enjoys a protein shake, but now he doesn’t get the “shakes” from dangerous weight loss drugs. . He’s thrilled that… “…For the First Time In My Life, I’m Not Using Any Weight Loss. He writes: “With Carolyn…I soon. ever before.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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The Pharma Data

MAY 15, 2021

And today only, we are going to give you free shipping and handling… But both the discount and the free shipping are for today only … So Choose The 6 Bottle Package (Or Any Other Package That’s Right Below) … And Secure An Order Today While There Are Supplies In Stock! Your Investment Today Is Also Covered By A.

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The Pharma Data

MAY 13, 2021

And what good are drugs that target your thyroid…. So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now…. Once you’ve selected your package…. Right now I want you to go ahead and select one of the three packages you see below….

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Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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Agency IQ

OCTOBER 20, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Codon

JUNE 2, 2024

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

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Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th 4th 1263 (9th Cir.

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Drug & Device Law

SEPTEMBER 12, 2023

If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic Act (“FDCA”), it’s probably a good idea for your expert so opine. Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic.

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Drug & Device Law

JULY 25, 2022

We post way too many pictures of the Drug and Device Little Rescue Dogs. A package of hot dog rolls is labeled “Hamburger Buns.” The court concluded, “. [B]ecause B]ecause the opinions in [the expert’s] report pertain only to transvaginal implantation, [the] testimony would be unhelpful to a jury. So far, so good. Cop-out #3.

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Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 801.109(c). 3d at 1286.

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Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d 3d 75 (Fla.

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Drug & Device Law

MAY 30, 2022

That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. That “common and widely known side effect” of many “chemotherapy drugs,” id.

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