FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology.

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. dwf_admin Fri, 01/05/2024 - 12:43 Source Hardon A. As Crary ( 2013 , p. But working at night is not necessarily good for us. Amphetamines were discovered shortly thereafter by chemists. Chemical 24/7. Chemical Youth.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Panel members flagged potential issues with variability between providers.

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Agency IQ

JUNE 17, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JUN 13, 2024 5:57 PM CDT Background: What is standing, and why is it important to the FDA? They were not subject to any direct regulation by the FDA related to mifepristone. Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone,” the court wrote.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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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. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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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 anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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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. pricing, among other things.

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Agency IQ

JANUARY 4, 2024

BY AMANDA CONTI, CHELSEY MCINTYRE, PHARMD | JAN 3, 2024 5:44 PM CST Background: Benzene impurities The U.S. One impurity of concern to regulators is benzene, which the Q3C guideline classifies as a Class 1 impurity, or a solvent that should be avoided due to its carcinogenic and environmental hazard properties.

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Drug Discovery World

JUNE 20, 2024

billion 1 is the estimated cost of bringing a new drug from the drawing board to pharmacy shelves today. With nearly 479,000 trials 6 registered globally as of early 2024, we are facing an outright data avalanche. Accessed Jan 2024. Accessed Feb 2024. Accessed Feb 2024. Accessed Feb 2024. Accessed Jan 2024.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Prohibition on Excessive Price Increases The law prohibits manufacturers from imposing or causing to be imposed an “excessive price increase,” whether directly or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state.

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Agency IQ

NOVEMBER 27, 2023

The changes, which should take effect in mid-2024, should result in drug ads with fewer distracting elements and more emphasis on the major risks of the drug. Previously, the proposed regulation was more specific as to the types of distractions (“statements, text, images, or sounds or any combination thereof”).

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Agency IQ

JULY 12, 2024

BY KIRSTEN MESSMER, PHD, RAC | JUL 10, 2024 11:16 PM CDT Background on medicines shortages and recent policy making regarding medicines shortages Medicines shortages have been identified as a major health concern in Europe for many years now. See AgencyIQ’s analysis of EMA’s milestones.] Read AgencyIQ’s analysis of the non-paper.]

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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. BY CHELSEY MCINTYRE, PHARMD | MAR 20, 2024 10:32 PM CDT Background: Drug compounding in the U.S. Now, the proposed list is out, and its limited length may be a surprise to stakeholders.

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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.

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Drug Discovery World

JULY 27, 2023

As reported by the BMJ, Sunak, introducing the Windsor framework at a press conference on 27 February, said, “From now on, drugs approved for use by the UK’s medicines regulator will be automatically available in every pharmacy and hospital in Northern Ireland.”

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

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Agency IQ

AUGUST 2, 2024

By Laura DiAngelo, MPH | Jul 29, 2024 9:52 PM CDT First up: HHS has a new digital technology office In July 2024, the Department of Health and Human Services (HHS) announced a reorganization of its digital health functions. Meanwhile, life sciences companies operating in Europe are readying for the AI Act’s implementation.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? In most states, this defers to the USP recommendation.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 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.

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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. This is what OIRA is currently reviewing.

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Codon

FEBRUARY 13, 2024

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. Phage therapies are sold at a pharmacy in Georgia.

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Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more.

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Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

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