Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

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Agency IQ

OCTOBER 6, 2023

Pharmaceutical industry worries The European Federation of Pharmaceutical Industries and Associations (EFPIA) communicated last week that the proposed restriction on PFAS could severely harm, or even halt, medicines manufacturing in the EU.

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Agency IQ

JUNE 26, 2023

incentives for rare disease-focused drug development were first enacted in 1983 under the Orphan Drug Act, including market exclusivities (7 years of marketing exclusivity), waivers from certain user fees, and tax credits for certain development activities (currently worth 25% of development costs). In the U.S.,

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Agency IQ

JANUARY 19, 2024

BY KIRSTEN MESSMER, PHD, RAC | JAN 17, 2024 9:16 PM CST Quick background: EMA annual new medicines reports At the beginning of each calendar year, the EMA publishes a New Medicines Highlights report, providing a high-level overview of new medicines reviewed by the EMA’s Committee for Medicinal Products of Human Use (CHMP).

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Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Here, AgencyIQ analyzes the root causes of these delays, and whether a trend could emerge in the coming years.

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Agency IQ

MAY 17, 2024

BY RACHEL COE, MSC | MAY 10, 2024 5:19 PM CDT Generic Drug User Fee Amendments (GDUFA) III The Generic Drug User Fee Agreement (GDUFA) was first passed in 2012 as part of the FDA Safety and Innovation Act (FDASIA) to bolster FDA’s resources for the review and approval of generic drugs. What to expect on the day of the meeting?

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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. Read AgencyIQ’s analysis of the non-paper.] Officials used a stepwise approach, they said.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. provides a 10-year market exclusivity period. Orphan designation in the E.U. countries examined between 2010 and 2017. member states.

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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. In some cases, the groups requested ad-by-ad reviews, potentially via collaboration with independent market research organizations. Interestingly, Merck & Co.

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Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” Should potency assurance plans be submitted? If so, how?

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics.

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Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. pharmaceutical law ceased to apply to the U.K. s single market. member states. s official exit from the E.U.

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The Pharma Data

NOVEMBER 2, 2020

In preparation of the proposal, market practice in the US for peer companies has shown that the percentage for allocation to employees already employed normally amount to 10 to 150 per cent of the yearly Base salary, whereby the proposal in US Co-worker LTIP 2020 is that the allocation is limited to 10 to 100 per cent of the yearly Base Salary.

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Agency IQ

JUNE 21, 2024

An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024. BY KIRSTEN MESSMER, PHD, RAC | JUN 20, 2024 11:49 PM CDT Regulatory background: Post-authorization lifecycle management Medicinal products may be authorized nationally in specific E.U. countries, in all E.U.

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Agency IQ

JANUARY 26, 2024

BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed.

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. market with Wegovy will, by 2030, require about one million liters of production capacity.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The report must be published within 120 days of each new fiscal year.

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Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Delays In the early 1980s, eager to push artemisinin onto the international market, China turned to the World Health Organization (WHO). Asimov Press (2024). Cite this essay: Wendi Yan.

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Agency IQ

JANUARY 12, 2024

But while the plan may be approved, the decision by FDA still leaves open plenty of questions – and the potential that pharmaceutical trade groups may sue to halt the implementation of the plan. The second program allows manufacturers to import their own products from Canada as “multi-market approved (MMA)” products.

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Codon

FEBRUARY 13, 2024

3 Another considerable obstacle to pharmaceutical companies’ interest (and investment) is the fact that for a product to be patentable — and therefore profitable — it has to be considered new and inventive. Asimov Press (2024). 4 But the same barriers still exist today. Cite this essay: Tom Ireland.

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. has a strong voice in the world. citizens; 2.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

DECEMBER 15, 2023

The EPA has scheduled 20 separate actions to be released in April 2024 alone. Meanwhile, EPA has extended the release of the final rule for Updates to New Chemicals Regulations under TSCA from April 2024 to February 2025. This routine Methods Update Rule (rMUR) was proposed in February 2023.

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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. For increased flexibility in bringing PIPs to market, a developer can also submit both. Comite Progreso de Lamont v.

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.

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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. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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Drug & Device Law

DECEMBER 29, 2023

F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation , 65 F.4th 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). Forest Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc. See you in 2024. 4th 851 (6th Cir.

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Drug & Device Law

FEBRUARY 19, 2024

Ortho Pharmaceutical Corp., Often, if not always, the “special controls” for a given FDA regulated product will specify that said product can only be marketed for prescription use and is thus exempt from providing “adequate directions for use” to lay patients. 2024 WL 477523, at *3 (Mag. Then there’s Oregon. 2d 522, 528 (Or.

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Licensing Licensing Regulations FDA 52

Drug & Device Law

FEBRUARY 29, 2024

We are medical device and pharmaceutical lawyers, so preemption is our thing. 3d __, 2024 U.S. LEXIS 22420, 2024 WL 487769 (C.D. 2:23-cv-2853 WBS DB, 2024 U.S. 21, 2024)). What could be better than preemption? How about “immunity”? Or is it that the same thing by a different name? CV 23-9082-JFW(JPRX), __ F.Supp.3d

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