2003, Pharmaceuticals, Regulations and Research

Analysis Chemical Thank You What we expect the EPA to do in July 2023

Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Compliance International Engineering

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

The Pharma Data

DECEMBER 15, 2020

TWO) for actinic keratosis in Taiwan and has partnered with Xiangxue Pharmaceuticals (SHE:300147) for actinic keratosis in China, Hong Kong, and Macau. Founded in 2003, Athenex, Inc. Athenex has partnered with Almirall (Almirall, S.A., In addition to the partnership with Almirall, Athenex has partnered with PharmaEssentia (6446.TWO)

FDA Approval

FDA Approval FDA Treatment Small Molecule

Decentralised identities: Blockchain based informed consent

Drug Discovery World

FEBRUARY 20, 2024

An investigation by Lentz and co-workers from the Clinical Trials Transformation Initiative (CTTI) identified four key topics as areas for improvement in Informed Consent: defining an effective ICP, training research staff, improving the informed consent document (ICF) and exploring the use of eConsent 2. Ther Innov Regul Sci.

Clinical Trials

Clinical Trials Pharma Companies Trials Compliance

Decentralised identities: Blockchain based informed consent

Drug Discovery World

FEBRUARY 20, 2024

An investigation by Lentz and co-workers from the Clinical Trials Transformation Initiative (CTTI) identified four key topics as areas for improvement in Informed Consent: defining an effective ICP, training research staff, improving the informed consent document (ICF) and exploring the use of eConsent 2. Ther Innov Regul Sci.

Clinical Trials

Clinical Trials Pharma Companies Trials Compliance

Analysis Chemical Thank You What we expect the EPA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

What we expect the EPA to do in October 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Compliance Science Marketing

Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science

Science Regulations International FDA

Analysis Chemical Thank You What we expect the EPA to do in January 2024

Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Compliance Government Science

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. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). Medicis Pharmaceutical Corp. ,

Production

Production International Trials Government

50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

Drug & Device Law

JUNE 1, 2023

So we decided to research state-law for decisions recognizing the gatekeeping role of courts tasked with determining the admissibility of expert testimony. Merrell Dow Pharmaceuticals, Inc. , Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. 2003); see also Sherwin-Williams Co. The search was simple.

Testimonials

Testimonials Trials Science Government

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices.

FDA

FDA FDA Approval Testimonials Vaccine

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Kent , 552 U.S.

FDA

FDA Regulations Production Government

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. 644 (2003), but not to Pike. Ogden , 22 U.S. Wisconsin , 228 U.S. 115 (1913), and Savage v. 501 (1912).

Regulations

Regulations Production FDA FDA Approval

Drug Discovery Digest

Analysis Chemical Thank You What we expect the EPA to do in July 2023

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

Trending Sources

Decentralised identities: Blockchain based informed consent

Decentralised identities: Blockchain based informed consent

Analysis Chemical Thank You What we expect the EPA to do in October 2023

Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Analysis Chemical Thank You What we expect the EPA to do in January 2024

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

50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

The FDA and Feasible Alternative Designs

Logical Contradiction Doctrine: Buckman for Textualists

NPP, DCC, And FDA-Regulated Medical Products

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