The Pharma Data

NOVEMBER 16, 2020

We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices. Food and Drug Administration (FDA) to submit data from its ongoing stability testing for approval.

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. What is drug compounding?

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Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. The size of the trials was comparable to those of new molecular entities—drugs that have never before been approved by the FDA. million). “We

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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The Pharma Data

MAY 13, 2021

I’ll also show you why their top scientists are now saying that this breakthrough treatment could replace traditional medical approaches for a wide range of painful conditions… What this means is that you can now say goodbye to your daily aches and pains without harmful drugs or having to resort to painful surgery. he continued.

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Advarra

DECEMBER 14, 2022

Pharmacy manual. Approval letter from the Centers for Medicare & Medicaid Services (CMS), including investigational device exemption (IDE) devices. drugs and biologicals. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. Optional Documents. Lab manual.

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Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN. In GenBioPro, Inc.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. United States Department of Health and Human Services , 58 F.4th 4th 696 (3d.

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Drug & Device Law

JUNE 2, 2022

Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate. This is not a matter of us injecting our personal and political views into areas we do not belong.

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). & Com.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.”

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Drug & Device Law

OCTOBER 10, 2023

Plaintiff has listed its patches on the FDA’s National Drug Code (“NDC”) database. Doing so comes with obligations to comply with FDA’s labeling requirements for such OTC drugs, which Plaintiff alleges they do. That’s the FDA’s job, not the court’s. That’s the FDA’s job, not the court’s. 341 (2001).

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Drug & Device Law

MAY 10, 2023

The FDA, for all of the criticisms leveled against it, has a lot of expertise and energy when it comes to approving drugs and devices. It is simply unworkable, even nonsensical, to permit the states to impose varying, contradictory requirements on FDA-approved products. And then there is the Supremacy Clause.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. The most prominent litigation in this space these days relates to reproductive rights. Ogden , 22 U.S.

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