2023, Packaging, Pharmacy and Regulations

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

What is Special about September 24, 2023 for the UDI System?

FDA Law Blog: Biosimilars

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. So, what is special about September 24, 2023? By Philip Won & Lisa M.

Packaging

Packaging Compliance FDA Pharmacy

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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.

FDA

FDA Science Regulations Production

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

Regulations

Regulations Drugs International Pharmacy

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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 latest update, announced this week, is known as the Spring 2023 Unified Agenda.

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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.

FDA

FDA Science Regulations Production

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. One of the things required by the Commissioner in October 2023 was an analysis of the E.U.

Regulations

Regulations Packaging Production FDA

Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

FDA

FDA Science Drugs Regulations

Scaling Phage Therapy

Codon

FEBRUARY 13, 2024

Fast forward to 2023. Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

Therapies

Therapies Virus DNA Clinical Trials

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

Regulations

Regulations FDA Science Production

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

Testimonials

Testimonials FDA Drugs Vaccine

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

FDA letter , December 14, 2023 (by Peter Marks, director CBER) (emphasis original). The “result” alleged was that “[a]s of November 10, 2023, Texans have been administered almost 30 million. . . 2023) (finding defendant’s vaccine to be a covered countermeasure; preempting all claims), review denied (Kan. 25, 2023); Goins v.

Vaccine

Vaccine FDA FDA Approval Pharmacy

N.D. Cal. Sees No Standing or Merit in Eye Cosmetic Claims

Drug & Device Law

OCTOBER 25, 2023

We don’t remember what the legislation was about, but we do remember the consumer affairs guy regaling us with stories about how easy it was for state investigators to find all sorts of violations of consumer fraud regulations. Weigh any packaged meat at a grocery store, and there’s a decent chance the weight will be wrong.

FDA

FDA Packaging Production Regulations

Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

What is Special about September 24, 2023 for the UDI System?

Trending Sources

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Scaling Phage Therapy

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

A Texas Mess

N.D. Cal. Sees No Standing or Merit in Eye Cosmetic Claims

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