2007, Licensing and Regulations - Drug Discovery Digest

2007

Licensing

Regulations

Treatment Plans That Worked

The Pharma Data

MAY 13, 2021

The Executive Director of the Institute for Behavior Change (IBC), licensed psychologist and certified school psychologist Steve Kossor, has been involved in the planning and delivery of what became known as Intensive Behavioral Health Services (IBHS) in Pennsylvania since 1981. push(arguments)},i[r].l=1*new Watch this video to learn more.

Treatment

Treatment Production Licensing Licensing

Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression

The Pharma Data

DECEMBER 1, 2020

AXS-05 is also a sigma-1 receptor agonist; enhances brain levels of serotonin, noradrenaline, and dopamine, which are key neurotransmitters involved in the regulation of mood; and displays anti-inflammatory properties, which may be relevant to treating depression. 2007) Am J. AXS-05 is covered by more than 93 issued U.S.

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Bridging Innovation & Patient Care: The Growing Role of AI

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Trending Sources

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

FDA

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Bridging Innovation & Patient Care: The Growing Role of AI

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Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations

Regulations Compliance Production Science

What is Protein Nitration? | BMG LABTECH

BMG Labtech

FEBRUARY 24, 2025

Protein nitration is one example that takes place on tyrosine residues which can have important consequences for the regulation of biological processes. 2007 Jul 15;75(2):291-302. 3 in this blog adapted from this reference under license CC-BY 4.0. 4 in this blog adapted from this reference under license CC-BY 4.0.

Small Molecule

Small Molecule Disease Licensing Licensing

The Codon Guide to Synthetic Biology

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Cell (2002).

DNA

DNA Cell Biology Molecular Biology Engineering

The Codon Guide to Synthetic Biology

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & & Xie X.S.

DNA

DNA Cell Biology Engineering Molecular Biology

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). 2007), held that “defective computer software may give rise to strict products liability in tort.”

Production

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NPP, DCC, And FDA-Regulated Medical Products

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. You never need an authorization from a licensed professional to buy pork or fireworks. Ogden , 22 U.S.

Regulations

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Mifepristone Manufacturer Wins First Round in West Virginia

Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. As Bexis’ article indicates, we like the chances of FDA regulation and the Supremacy Clause where there is a level playing field.

FDA Approval

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The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices.

FDA

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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. at 183 (quoting Meyers v. Donnatacci , 531 A.2d

Production

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Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. 124 (2007), which would also be knocked out by Dobbs if it sticks. the state action would be preempted. Strickland , 531 F.3d 3d 406 (6th Cir. Both of these cases applied the U.S. Humble , 753 F.3d

FDA Approval

FDA Approval Pharmacy FDA Drugs

Treatment Plans That Worked

Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression

Webinars

Trending Sources

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Webinars

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

What is Protein Nitration? | BMG LABTECH

The Codon Guide to Synthetic Biology

The Codon Guide to Synthetic Biology

How the Fifty States View Electronic Data as a “Product”

NPP, DCC, And FDA-Regulated Medical Products

Mifepristone Manufacturer Wins First Round in West Virginia

The FDA and Feasible Alternative Designs

Suing the Certifiers – A Dangerous Undertaking

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

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