Drug Channels

JUNE 25, 2024

Attendance will be limited, so click here to request an invite for our March 2025 event. Happy 248th birthday, America! Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only.

Biosimilars 40

Biosimilars Drugs Pharmacy 40

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.

Compliance 105

Compliance Drugs Pharmacy Licensing 105

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. The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Prehearing Ruling (Dec. 4, 2024), at 1.

Testimonials 52

Testimonials Regulations Drugs 52

FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

Drugs 59

Drugs Pharmaceuticals 59

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.

Biosimilars 40

Biosimilars Production Government Pharmaceuticals 40

The Pharma Data

JULY 29, 2021

Looking forward, we remain highly confident in our ability to achieve at least a 6% compound annual growth rate through 2025 and intend to build upon our recent successes by continuing to follow the science, trust in our people and remain focused on delivering breakthroughs for the patients we serve.”. Revenues $45.0 to $2.60).

Vaccine 52

Vaccine Biosimilars Production International 52

FDA Law Blog: Biosimilars

MARCH 21, 2024

MoCRA requires that FDA issue a report on PFAS in cosmetics by the end of 2025, but one takeaway from these discussions was that several states laws create a patchwork of relevant laws, further complicated by a plaintiffs’ bar that is aggressively pursuing class action lawsuits.

Production 64

Production Compliance Regulations FDA 64

FDA Law Blog: Biosimilars

JUNE 14, 2023

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., up to 125 total products enrolled through FY 2025). up to 60 total products enrolled through FY 2024).

Production 45

Production FDA Clinical Trials Marketing 45

FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Compliance 64

Compliance Laboratories FDA Regulations 64

FDA Law Blog: Biosimilars

JULY 6, 2023

We remain cautiously optimistic of the timeline given the extensive and competing priorities CDRH has in front of them, including: implementing provisions required under the Food and Drug Omnibus Reform Act (FDORA) (which we summarized and analyzed here ), meeting performance goals set forth in MDUFA V , working on their 2022 – 2025 strategic priorities (..)

Regulations 52

Regulations FDA Drugs 52

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Stage 1 is scheduled to take effect on May 6, 2025. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. A: According to the Agency, the lab would be considered a manufacturer of the new, modified test and must follow applicable regulatory requirements, including MDR requirements.

FDA 64

FDA Laboratories Regulations Compliance 64

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.

FDA 59

FDA Drugs Production 59

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

The draft guidance indicates that this timetable will be announced by September 30, 2025. Timeline FDA notes that when this draft guidance is finalized, it will specify the corresponding timetable(s) for the implementation of De Novo electronic submissions.

FDA 52

FDA Virus Regulations Production 52

Agency IQ

AUGUST 2, 2024

All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity. legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

Regulations 40

Regulations Clinical Trials Production Trials 40

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. If it does, the letter will also identify the device class, whether a premarket notification or premarket approval is required to market the device, and other pertinent information.

FDA 69

FDA Regulations Production Marketing 69

Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. The changes to the EMA’s Fee Regulation (Regulation (EC) No 297/95) could be adopted during this month’s planned plenary meeting.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Biosimilars

JUNE 7, 2023

the Medicaid Drug Rebate Agreement and the Medicare Part D Coverage Gap Discount Agreement or the agreement under the successor Part D discount program that begins in 2025), Merck characterizes that as a coercive penalty for the refusal to forfeit its First and Fifth amendment rights.

Government 45

Government Compliance Drugs Production 45

Agency IQ

JULY 8, 2024

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

Positive *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q2 2024.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

MAY 31, 2024

Program Agency Deadline Survey: EU4Health Annual Work Program 2025 European Commission 6/10/2024 Survey: Real4Reg survey on real-world data Real4Reg/EMA 6/14/2024 Survey: EMA Communication perception EMA 6/21/2024 Survey: E.U. These include, but are not limited to, calls for applicants, expressions of interest and surveys.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

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

Production 52

Production Clinical Trials International Small Molecule 52

Agency IQ

MARCH 29, 2024

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

FDA Law Blog: Biosimilars

JUNE 21, 2023

Background – Strategic Priority to Advance Health Equity In CDRH’s 2022-2025 Strategic Priorities , “Advance Health Equity” is listed as one of the three strategic priorities along with “Promote a Modern and Diverse Workforce” and “Enhance Organizational Agility and Resilience.”

Clinical Trials 45

Clinical Trials FDA Trials Treatment 45

Agency IQ

JULY 8, 2024

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Agency IQ

OCTOBER 27, 2023

11/9/2023: Enters into force 11/9/2025: Date of application To contact the authors of this resource, please email Sierra Milam ( smilam@agencyiq.com ). To contact the editor of this resource, please email Chelsey McIntyre ( cmcintyre@agencyiq.com ).

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Biosimilars Clinical Trials 40

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

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

FEBRUARY 8, 2021

price, patients switching to Toujeo ® and biosimilar glargine competition. to €189 million) reflecting recent guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients which more than offset biosimilar competition in several European countries. Full-year 2020 franchise sales were down 4.8%

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

price, patients switching to Toujeo ® and biosimilar glargine competition. to €189 million) reflecting recent guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients which more than offset biosimilar competition in several European countries. Full-year 2020 franchise sales were down 4.8%

Vaccine 52

Vaccine Production FDA Therapies 52

Agency IQ

SEPTEMBER 1, 2023

Products eligible to qualify for the IRP include chemical and biological new or known active substances ( Regulation 50 ), generics ( Regulation 51 ), biosimilars ( Regulation 53 ) and fixed combination products ( Regulation 55 ). centralized procedure until 2025, when the Windsor Framework takes effect. IRP approvals using the E.U.

International 40

International Regulations Production Marketing 40

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. Thankfully, we have until December 31, 2025 to ruminate about it. The federal telemedicine flexibilities (i.e.,

FDA Approval 52

FDA Approval Regulations Pharmacy Licensing 52

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Comments on the proposed order are due May 25, 2025. As dictated by the process provided for in the 2020 CARES Act, FDA announced issuance of the proposed order in a Federal Register notice and published the proposed order itself on FDA’s website. That means almost certainly no sooner than the second half of 2026.

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FDA Production Pharmacy International 111

FDA Law Blog: Biosimilars

MAY 23, 2024

Even if the upcoming elections result in a change in Presidential Administration or composition of the Senate, FDA’s Final Rule would be ineligible for review under the CRA, as the 60 legislative days will have elapsed by January 2025. The lab industry should be watching closely for litigation and legislative developments.

Regulations 52

Regulations FDA Laboratories 52

Drug Channels

NOVEMBER 12, 2024

president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. Fein, Ph.D., to 1:30 p.m. Or, just click here to order.)

Biosimilars 83

Biosimilars Drugs Pharmacy Marketing 83