2002, Licensing and Regulations - Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

The review builds on several data sets, including large IQVIA/MIDAS data sets of products authorised between 2002 and 2020. They explain that a number of studies have demonstrated how incentives influence company development and innovation decisions, such as through the industry-standard risk-adjusted Net Present Value (rNPV) model.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

Article EMA Thank You U.K. regulator lays out proposal for international device and diagnostics recognition

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International

International Regulations Licensing Licensing

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

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. An “outsourcing facility” per Section 503B is a registered location that engages in the compounding of sterile drugs but is not required to be a licensed pharmacy.

FDA

FDA Pharmacy Production Drugs

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

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

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. That would leave 19% of staff affected by furloughs.

FDA

FDA Science Biosimilars Regulations

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. & Cell (2002).

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. 2002), held that Connecticut law would follow the definition of “product” as “tangible personal property distributed commercially for use or consumption.” at 77 (citation omitted). In United States v. Brown , 348 F.3d

Production

Production International Trials Government

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

2002); Tracker Marine, L.P. 2002 WL 32830975, at *4 (Tex. May 15, 2002); Bass v. 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. See Henry Schein, Inc. Stromboe , 102 S.W.3d

Vaccine

Vaccine FDA FDA Approval Pharmacy

FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

NOVEMBER 9, 2023

357 (2002); United States v. If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. E.g. , Sorrell v. IMS Health Inc. ,

FDA

FDA Nurses Production Regulations

The Medical Device Labeling Exception for “Commonly Known” Hazards

Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

Testimonials

Testimonials Licensing Licensing FDA

Preemption as a Backup for the Learned Intermediary Rule

Drug & Device Law

FEBRUARY 19, 2024

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings – called “adequate directions for use” – are not necessary for drugs or devices that are available only with a physician’s prescription. For drugs, the relevant regulation is 21 C.F.R. Ortho Pharmaceutical Corp., 2d 522, 528 (Or.

Licensing

Licensing Licensing Regulations FDA

Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

Article EMA Thank You U.K. regulator lays out proposal for international device and diagnostics recognition

Trending Sources

Treatment Plans That Worked

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

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

The Codon Guide to Synthetic Biology

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

The Codon Guide to Synthetic Biology

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

A Texas Mess

FDA and Off-Label Communication – Getting Closer to Truth

The Medical Device Labeling Exception for “Commonly Known” Hazards

Preemption as a Backup for the Learned Intermediary Rule

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