FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R.

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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.

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The Premier Consulting Blog

OCTOBER 1, 2023

The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. Prescription Drug User Fee Act (PDUFA) VII The Prescription Drug User Fee Act (PDUFA VII) is a law that was signed and took effect on September 30, 2022.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. billion by 2027. NEW YORK , Jan. Q BioMed Inc.

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Alta Sciences

JANUARY 31, 2025

It owned the societal name of the Canadian Association for Research on Drug Safety. As experts in early-phase drug development , from discovery through Phase II clinical research , we at Altasciences can share with STC members our accumulated knowledge and experience, and provide mentorship for future toxicologists.

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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.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. Like in the multitude of Orphan Drug Act cases preceding this one, Jazz alleges that FDA’s authority under the Orphan Drug Act was limited by the statutory language.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. Opinion at 17. contradicts the plain text of the statute and therefore must be set aside.” . ; see also 42 U.S.C.

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FDA Law Blog: Biosimilars

JUNE 7, 2023

Kirschenbaum — The Inflation Reduction Act’s price negotiation program for drugs covered under Medicare Parts B and D (“Negotiation Program”) has been challenged in federal court. to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value.

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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.

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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. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.

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Agency IQ

SEPTEMBER 6, 2023

FDA Warning Letters are often sent to manufacturers of generic drugs. Such products are often made in foreign facilities by staff less experienced with FDA regulatory requirements and at margins which may preclude significant investments in drug quality.

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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. About BridgeBio.

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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

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Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

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Agency IQ

SEPTEMBER 15, 2023

SEP 11, 2023 10:49 PM CDT Regulatory background Cosmetic ingredients in California are governed by the Federal Food, Drug & Cosmetic Act (FD&C Act), which provides that cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration ( 21 CFR 701.3 ).

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Agency IQ

MARCH 15, 2024

The regulation is focused on shifting the plastic pollution burden from consumers to producers, and requires the PRO to remit $500 million to the state each year between 2027 and 2037 for the California Plastic Pollution Mitigation Fund (totaling $5 billion).

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Agency IQ

AUGUST 18, 2023

In 2022, the MDCG offered a guidance document on the borderline between drugs and devices, and the manual itself containing decisions on products came out in September 2022. We’ve seen what’s been going on with the MDR, but the main concern we’ve heard of IVDR is the performance study application process is affecting drug trials.

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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.

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Agency IQ

NOVEMBER 3, 2023

October 1, 2027) in order to align with the next iteration of the device user fee program, the QS compliance requirement for LDTs could theoretically be in place by FY2027. The system as proposed could have compounding implications across the life sciences industry, including for drug development.

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Drug Target Review

JUNE 5, 2023

Can you tell us more about ZW191 and its potential as an FRα-targeting antibody-drug conjugate? ZW191 is comprised of a novel fully humanised IgG1 antibody covalently conjugated to a novel topoisomerase 1 inhibitor ZD06519, a camptothecin derivative, via endogenous interchain cysteines with a drug-to-antibody ratio (DAR) of eight.

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Agency IQ

FEBRUARY 15, 2024

Priority A List.

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FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—several other statutory provisions that were scheduled to expire.

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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.

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Agency IQ

AUGUST 2, 2024

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

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Agency IQ

OCTOBER 20, 2023

A January 2022 Seminars in Arthritis and Rheumatism publication noted that a “generic [drug] may only cost $1 million to $4 million and take two years to develop vs $100 million to $250 million and seven to eight years for a biosimilar.” Those studies lasted a median of 55 weeks (IQR: 46-78) and cost a median of $27.6 million (IQR: $18-36.7

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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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. between 2020-2027. Additionally, in some cases, gene therapy treatments make permanent changes to a human’s genetic profile, which is different than typical drug treatments.

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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).

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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.

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Agency IQ

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes.

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Codon

OCTOBER 6, 2024

Blood tends to coagulate when it comes into contact with foreign materials, and for life-support systems like ECMO to work in adults, the blood is typically thinned using drugs such as heparin. Another major issue in human babies is blood clotting.

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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.

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Agency IQ

DECEMBER 1, 2023

The standards would begin with model year 2027 heavy-duty vehicles, with stringency levels through model year 2030 and beyond. This action is also supported by the President’s Executive Order 14037, titled “Strengthening American Leadership in Clean Cars and Trucks.

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Agency IQ

JUNE 16, 2023

The standards would begin with model year 2027 heavy-duty vehicles, with stringency levels through model year 2030 and beyond. The standards will begin with model year 2027 light-duty vehicles, with stringency levels set at least through model year 2030.

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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.

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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. .

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