Common Sense for Drug Policy Blog

JANUARY 5, 2024

Part of this 'performance' has to do with adapting to the different temporal demands of the labor market—in other words, the management of sleep and wakefulness. Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. As Crary ( 2013 , p.

Pharmacy

The Premier Consulting Blog

AUGUST 21, 2024

The major markets follow ICH guidelines, which affords harmonization of a significant portion of the chemistry, manufacturing, and controls (CMC) content. August 2021: [link] Pharmaceutical Regulations in Japan: Drug Development: [link] [link] [link] Stability conditions for WHO Member States by Region, March 2021: [link]

Clinical Development

The Pharma Data

NOVEMBER 4, 2020

From 2003 to 2014, Mr. Thoresen was the managing director of Nycomed Pharma AS acquired by Takeda Pharmaceutical Company Limited in 2011 as part of an acquisition transaction with a total value of approximately USD $14B. XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.: Hugh Rogers, CEO and Director.

Pharmaceutical Companies

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

The Pharma Data

DECEMBER 15, 2020

Klisyri will be manufactured by Athenex, highlighting the vertically integrated capabilities of the company ranging from a preclinical lead to a developed product for market launch. Mr. Peter Guenter, CEO of Almirall, stated, “We are delighted to partner with Athenex to market Klisyri in the U.S. Founded in 2003, Athenex, Inc.

FDA Approval

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. 2003) , and Biogen lnt’l v.

FDA Approval

Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

Regulations

The Pharma Data

NOVEMBER 9, 2020

About NANOBIOTIX: www.nanobiotix.com Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

Immune Response

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. These considerations led to several members finding ethical implications of keeping phenylephrine on the market.

Science

The Pharma Data

OCTOBER 19, 2020

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell. Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP).

Clinical Trials

Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. A company called LuminOre will soon bring copper-coated air ducts to the market. Not dissimilarly, biocidal products—those that destroy living things—must satisfy demanding regulations. Credit: Qi S.

Virus

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA

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. The FDA recently concluded its work on a proposed rule focused on PMI.

FDA

Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 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. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

Regulations

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

Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 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. TSCA risk management rules.

Regulations

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The illicit marijuana market remains strong despite state laws legalizing marijuana. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

Regulations

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

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations

Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

Regulations

BioPharma Drive: Drug Pricing

AUGUST 8, 2025

In 2003, the pharma giant began a complicated journey that was almost doomed from the outset. regulators but pulled from the market two years later due to low efficacy. Permission granted by AstraZeneca First published on For AstraZeneca, a single mutation has launched an entire blockbuster lung cancer franchise.

Clinical Trials

Policy Prescription

MARCH 12, 2021

Existing law, as found in the Medicare Prescription Drug Modernization and Improvement Act of 2003 (MMA), only allows wholesale drug importation from Canada (if safety and savings are certified by the HHS Secretary). State of Reform does a nice job covering this bill, but this post gives some underlying and important history.

Drugs

Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. 2002); Tracker Marine, L.P. Ogle , 108 S.W.3d

Vaccine

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. Charting which justices joined which opinions on which issues looks like a psilocybin-induced Venn diagram.

Regulations

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market. 2d 506 (N.Y.

FDA

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”). 2003), review denied (Cal.

Production

Drug & Device Law

JANUARY 30, 2023

Mensing , 564 U.S. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA

Drug & Device Law

NOVEMBER 16, 2023

The plaintiffs allege that ranitidine, which had been sold under the brand name Zantac before it was removed from the market, caused them or their decedents to develop cancer. GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). The court granted the motion and JAMA appealed. The appellate court reversed in Gibbons v.

Government

LifeSciVC

MAY 28, 2025

Further, the pace of fast follower drugs is striking relative the past: according to PhRMAs recent report on innovation , the average time for a drug class to have three FDA approvals in it went from ~15 years in 1990-2003 to ~2 years in 2013-2021. Market competition between startups happens very quickly, and often intensely.

Production