FDA Law Blog: Biosimilars

MARCH 15, 2023

s Ricardo Carvajal will be moderating a panel on “The Use of Bioactive Substances in Food and Dietary Supplements” during the Food and Drug Law Institute (FDLI) Food and Dietary Supplement Safety and Regulation Conference. Hyman, Phelps & McNamara, P.C.’s

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FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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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. By John W.M. Truly, these are complex considerations.

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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.

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FDA Law Blog: Biosimilars

JANUARY 8, 2024

Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. We won’t repeat ourselves, but we will summarize—regulatory due diligence and an understanding of historical regulatory compliance issues is a critical component of assessing whether a deal is what it seems to be.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 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

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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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh will contribute her extensive expertise in FDA regulatory matters to a session titled “Global Ad Promo and Enforcement Insights,” addressing the complex landscape of advertising and promotion compliance on a global scale. Attendees can expect to gain practical strategies for compliance and enforcement, drawn from Ms.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. Consent Agreement and Final Judgment ¶ 10.a.-n.

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Agency IQ

MAY 31, 2024

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.

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FDA Law Blog: Biosimilars

MAY 16, 2024

But there has been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA regulations allowed employees to divert staggering quantities of controlled substances.

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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 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply. FDA failed on each count.

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Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. The seamless use of Data Standards also require compliance with Data Integrity Standards. Author Information William E. Spanogle, Ph.D.

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Agency IQ

AUGUST 2, 2024

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.

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FDA Law Blog: Biosimilars

MAY 27, 2024

On the postmarket side, she advises clients on regulatory compliance matters, including complaint handling, MDRs, field actions, promotional review, and QSR compliance. Jennifer also helps clients with contract matters, regulatory due diligence, and public filings. She also specializes in medical device software and digital health.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development. Prior to Compliance Architects, Jeff held senior leadership positions as Conference Director and Director of Sales for industry leading provider FDAnews.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Audits and Compliance Monitoring: Using its discretionary authority under 42 U.S.C. CMS may similarly audit participating manufacturers up to once a year to monitor their compliance after a similar 60-day notice of a reasonable basis for the audit. Final Guidance at 15.

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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 21 CFR 820.20

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FDA Law Blog: Biosimilars

JULY 30, 2024

By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. GLP-1s – Exploring the Anticipated Compliance and Litigation Risks.

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. This annual gathering, renowned for its influential speakers and dynamic networking opportunities, will see Ms.

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FDA Law Blog: Biosimilars

OCTOBER 5, 2023

Earlier this year, DOJ’s CPB issued its own voluntary disclosure policy , which applies more broadly to potential criminal violations “involving the manufacture, distribution, sale, or marketing of products,” as well as “misconduct involving failures to report to, or misrepresentations to” regulators.

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FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms.

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FDA Law Blog: Biosimilars

DECEMBER 21, 2023

Those who attended their annual Enforcement, Litigation, and Compliance Conference holiday reception earlier this month got a sneak peek at this new branding effort with the unveiling of the association’s new logo ( here ). FDLI looks forward to this continued partnership for many more years to come.”

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Palmer , Larry K. Houck , and Kalie E.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.

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FDA Law Blog: Biosimilars

MARCH 9, 2023

This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the corporate compliance chart. Operate legitimate, bona fide, and well-resourced compliance programs. Inspire a culture of compliance. Prevent corporate wrongdoing before it happens. Classics, all.

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FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

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FDA Law Blog: Biosimilars

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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Vial

APRIL 10, 2024

Implemented within a cloud-native infrastructure, Vial’s unified EDC ensures a user-friendly experience while strictly adhering to security standards, including regulatory compliance with 21 CFR Part 11, HIPAA, and GDPR.

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