FDA Law Blog: Biosimilars

OCTOBER 6, 2023

These products are devices as defined in section 201(h) (1) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act, including when the manufacturer of these products is a laboratory.

Laboratories

Agency IQ

JULY 22, 2024

This database was created to share post-market surveillance information across E.U. Ultimately, this module will interact with CTIS , the drug clinical trial information system. The independent auditing schedule showed publication of full functionality in mid-2027. countries and Notified Bodies (NBs).

Regulations

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. billion, projected to grow at a compound annual growth rate (CAGR) of 6.9% between 2023 and 2032.

Clinical Trials

Agency IQ

JANUARY 26, 2024

Class A devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. In-house tests (in the U.S. called laboratory-developed tests manufactured and used in a single lab) had until May 26, 2024.

Regulations

The Pharma Data

JANUARY 25, 2021

This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. per share on the Nasdaq Global Select Market on January 25, 2021.

Marketing

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

Science

Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. Are there implications for drug or therapeutic developers?

FDA

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). years after publication; no earlier than October 1, 2027) End of Enforcement Discretion for: Premarket review for high-risk IVDs. On September 29, 2023, the U.S. Phase 4 (3.5

Laboratories

Agency IQ

NOVEMBER 3, 2023

The agency further proposed a five “stage” phaseout of its current enforcement discretion, which would walk in the medical device regulatory requirements – from adverse events reporting to pre-market review – over four years. Under the proposed rule, these tests would be able to continue operating under the current status quo.

FDA

Agency IQ

AUGUST 18, 2023

The registration database, EUDAMED , isn’t yet complete d, with just half of its planned modules released to production – actor registration, UDI and device registration, and Notified Bodies and certificates are live; still being worked on are the modules for clinical and performance studies, vigilance, and market surveillance.

Science

Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA. The format and organization of the CTD is outlined in the ICH M4 Guideline.

Science

BioPharma Drive: Drug Pricing

JULY 21, 2025

After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab). For the past few years, Stelara has been J&J’s top seller, earning $10.4 billion in 2024.

Biosimilars

FDA Law Blog: Biosimilars

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

Production

Agency IQ

FEBRUARY 15, 2024

Priority A List.

FDA

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps.

FDA

Agency IQ

AUGUST 2, 2024

legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

Regulations

BioPharma Drive: Drug Pricing

JULY 21, 2025

The developer of that treatment, Sarepta Therapeutics, informed the Food and Drug Administration his case could be life-threatening. But the Duchenne community mostly embraced Elevidys, propelling it to the fastest market launch of any gene therapy approved in the U.S. You can unsubscribe at anytime.

Therapies

Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% between 2020-2027.

Therapies

The Pharma Data

DECEMBER 30, 2020

Multiple drugmakers agreed to cut prices of some of their newest drugs by as much as 50% in order to receive coverage from China’s national insurance program. The companies agreed to the steep price cuts in order to have their drugs made available to the world’s second-largest pharmaceutical market. billion by 2027.

Immune Response

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. Food and Drug Administration (FDA). Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% hypoxia, cough, dyspnea).

Clinical Trials

Agency IQ

NOVEMBER 20, 2023

Sentinel Update: PDUFA projects, ARIA sufficiency and building out a method for causal inference FDA’s Sentinel Initiative, the post-market, real-world data surveillance system, is nearing the end of its current five-year strategic plan. The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA).

Science

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) recommendation that the Drug Enforcement Administration (“DEA”) reschedule cannabis federally from schedule I to schedule III would lead an outsider to conclude that commenters are referring to different substances. Letter to U.S.

Regulations

Agency IQ

DECEMBER 1, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

Regulations

Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

Regulations

BioPharma Drive: Drug Pricing

JUNE 30, 2025

Jacob Bell/BioPharma Dive Dive Brief: Moderna’s seasonal influenza vaccine met its main goal in a large Phase 3 trial, reducing the risk of influenza-like illness in people 50 years and older by 27% compared with those given a marketed shot targeting three or four strains of the virus, the company said Monday. By Jonathan Gardner • Sept.

Vaccine

Agency IQ

MARCH 29, 2024

March 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 (Final Rule Stage) 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

Regulations

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and. in December 2019; and.

Vaccine

Agency IQ

DECEMBER 15, 2023

March 2024 February 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 Final Rule Stage 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

Regulations

FDA Law Blog: Biosimilars

JULY 23, 2025

Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. 3 in food prior to the previously announced 2027 deadline.

FDA Approval

BioPharma Drive: Drug Pricing

AUGUST 13, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from AbbVie to build API plant in Illinois as it steps up US production The expansion is part of AbbVie’s larger $10 billion commitment to U.S. You can unsubscribe at anytime.

Production

The Pharma Data

NOVEMBER 25, 2020

The interim final ruling on most-favored-nation status for drug prices is expected to be published on November 27 th in the Federal Register by the Centers for Medicare & Medicaid Services (CMS) at the Department of Health and Huma Services (HHS). Specifically, one study of 27 drugs found the U.S. CMS maintains otherwise.

Drugs

Drug Patent Watch

JANUARY 6, 2025

The biopharmaceutical industry is witnessing unprecedented growth, with the Contract Development and Manufacturing Organization (CDMO) market expected to reach $289.64 billion by 2027. Monitor and Adapt Marketing Strategies CDMOs must continuously monitor and adapt their marketing strategies to stay ahead of the competition.

Marketing

Drug Target Review

MARCH 20, 2025

This development is not just a significant milestone in drug discovery, but also a potential breakthrough for clinical practice, as it may address a critical gap in current treatments by offering effective stroke prevention with a reduced risk of bleeding. .

Therapies