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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%
All these features make GPCRs central to regulating many vital biological processes in the body, including immune responses and inflammation, and thus especially attractive for therapeutic intervention. It also holds potential for neuroinflammatory conditions such as certain types of migraine.
Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (
Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.
As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.
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.
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.
Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. By Charles D. Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S.
The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products. And it is exactly that!
Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. That being said, we have no doubt that as the door to regulating LDTs directly has closed, absent new legislation, FDA is likely to look for a new door to open. By Steven J. Gonzalez & Allyson B. Stay tuned.
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.
Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. The RFI is open through July 14, 2025. The Announcement raises several questions and issues for the device industry.
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.
Snow — On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025. By Charles D.
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.
Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.
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.
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.
Clissold On January 21, 2025, the Trump administration withdrew FDAs proposed ban on menthol cigarettes, which the Biden administration initially introduced in 2022. By Sophia R. Gaulkin & Esther Petrikovsky & David B. This move is the latest step in FDAs long, uncertain, and controversial journey to ban menthol cigarettes.
Published July 22, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. and European life sciences companies.
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.
While the details of the expanded program are vague, this is a good opportunity for stakeholders across FDA-regulated industries around the world to ensure they are inspection ready. On July 29, 2025, ProPharma and HPM’s Kalie E. Richardson will be participating complimentary webinar on Avoiding Common Pitfalls During FDA Inspections.
By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda.
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.
The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.
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.
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
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Knowing how a product will be regulated is essential to companies. The District Court then vacated FDA’s classification decision to regulate the product as a drug a second time (see our previous post here ).)
Less than a month later, on July 14, 2025, FDA issued a Warning Letter to WHOOP, Inc., (“WHOOP”), stating that its wearable product, Blood Pressure Insights (“BPI”), is adulterated and misbranded because it is a regulated medical device that is being marketed without FDA clearance or approval. Emphasis added.)
The requirement for the single-unit or unit-dose containers is not a substitute for special packaging, i.e., child resistant packaging required for certain products under the Poison Prevention Packaging Act and implementing regulations. See 16 C.F.R.
For any blog reader who has ever missed that cancellation deadline and found themselves saddled with another month (or year) of a streaming service or gym membership, this decision may be of personal interest, but, for regulated industry, it highlights how a procedural win can sometimes be a full victory. On July 8, 2025, the U.S.
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.
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.
Kirschenbaum — The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule ( here ), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting. The payment limit for most Part B drugs is ASP plus 6 percent. with certain exceptions.
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.
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.
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.
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
What we expect European regulators to do in August and September 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.
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.
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.
What we expect European regulators to do in June 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.
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.
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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