Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 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.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new 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.

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FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. Final Guidance at 2.

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FDA Law Blog: Biosimilars

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. By Steven J. Gonzalez & Lisa M. 21 CFR 820.20

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FDA Law Blog: Biosimilars

DECEMBER 12, 2024

Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. A limited number of affidavits may be received into the record subject to the evidentiary weight adjustment specified in the regulations. Prehearing Ruling (Dec. 4, 2024), at 1.

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The Pharma Data

MAY 18, 2021

Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. About Sandoz.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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FDA Law Blog: Biosimilars

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. In FY 2025, continue to support products enrolled in previous fiscal years and expand to enroll up to 65 additional products in at least four OHTs (i.e.,

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. The draft guidance indicates that this timetable will be announced by September 30, 2025. There will be a transition period before requiring all De Novo requests to be submitted electronically.

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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.

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The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. CAPITAL ALLOCATION. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S. billion on revenues and approximately $0.09

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new 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.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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FDA Law Blog: Biosimilars

MAY 23, 2024

Gonzalez — On May 15th and 16th, respectively, Senator Rand Paul and Congressmen Brad Finstad and Dan Crenshaw introduced Senate and House resolutions “providing for congressional disapproval under chapter 8 of title 5, United States Code” of FDA’s Final Rule to regulate Laboratory Developed Tests (LDTs).

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Drug Patent Watch

JANUARY 13, 2025

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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FDA Law Blog: Biosimilars

MARCH 31, 2025

Gonzalez On March 31, 2025, U.S. That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests. By Steven J. District Judge Sean D.

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FDA Law Blog: Biosimilars

MARCH 23, 2025

Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. By Deborah L.

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FDA Law Blog: Biosimilars

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

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FDA Law Blog: Biosimilars

JANUARY 14, 2025

By Ritte van Laack A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. As we previously reported, MoCRA includes various provisions requiring that FDA develop regulations within a specific time frame. FDAs report card therefore shows a big Incomplete.

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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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FDA Law Blog: Biosimilars

MARCH 12, 2025

The American Conference Institutes 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY. Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the U.S.

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FDA Law Blog: Biosimilars

APRIL 6, 2025

2, 2025) that affirms FDAs denial of authorization to market flavored vape products. The Courts decision marks an end to the circuit split caused by the Fifth Circuits en banc panel on this specific issue, but we fully expect continued litigation and regulation over this hot topic. Clissold & Sophia R. 23-1038 (Apr.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

Hospitals that fail to fulfill their obligations under the federal Controlled Substances Act and DEA regulations pose serious health risks to patients for undertreatment and worse, and to employees for overdose and death. Employee diversion can also result in unwanted local and national publicity.

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FDA Law Blog: Biosimilars

MARCH 25, 2025

Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. By Adrienne R.

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FDA Law Blog: Biosimilars

JANUARY 13, 2025

Although there are no regulations on the specific conditions to make such a claim, the claim must be truthful and not misleading. By Sophia R. Allergen-Free Claims : FDA addressed allergen-free claims, confirming that firms may make voluntary statements on product labeling that certain allergens are absent from the product.

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FDA Law Blog: Biosimilars

JANUARY 20, 2025

Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements , on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods. Comments on the draft guidance may be submitted until May 7, 2025.

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. She already has broad-based exposure to a variety of FDA regulated products. Richardson has been promoted to Director.

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? By Richard A.

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FDA Law Blog: Biosimilars

JANUARY 5, 2025

Finally, FDA revised language in the final regulation about the circumstances under which a drug product with an ACNU would be misbranded though it is not clear that the language actually clarifies all that much. The final rule becomes effective on January 27, 2025.

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations. The federal telemedicine flexibilities (i.e.,

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). Comments on the Draft AI Guidance are due by April 7, 2025. By Adrienne R.

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FDA Law Blog: Biosimilars

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. The DCP should follow applicable regulations governing human subject protections, where applicable. By Adrienne R. Some disease conditions may not be as prevalent and the DCP should describe any enrichment strategies to ensure subgroups are represented.

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