FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. 21 U.S.C. § 1310.06.

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FDA Law Blog: Biosimilars

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. Additional information, including a preliminary agenda, is available at the conference webpage here.

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Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Download a free report overview for more details.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

The GAO Report provides an overview of the rulemaking process for OTC hearing aids, the resulting OTC hearing aid regulatory scheme, and FDA’s interaction with other agencies when regulating OTC hearing aids. While helpful background, it’s not new information.

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FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. Prior notice” informs FDA about the products it can expect to be offered for import into the country. By Sophia R.

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” FDA investigators routinely share their names, titles, contact information, and, when appropriate, reasons for conducting the inspection. By Sarah Wicks & Anne K. Ask clarifying questions.

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FDA Law Blog: Biosimilars

MARCH 12, 2023

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. Please see detailed information in the attached flyer , including a link to register for our free webinar. Hyman, Phelps & McNamara, P.C.’s We hope you join us!

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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

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

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Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

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Agency IQ

JUNE 29, 2023

Industry should take note of some of the consequential changes in the final guidance, including those related to the presentation of information about control groups, which will likely apply to many drug advertisements. The FDA regulates prescription drug advertising under 21 CFR 202.1 , Prescription drug advertisements.

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

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FDA Law Blog: Biosimilars

JULY 31, 2023

Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 78,282 (Dec. 46,983 (July 21, 2023). codified at 21 C.F.R.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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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. Youth behavioral data was not specifically required but FDA encouraged such information. But they did not submit information specific to flavored products. In Wages and White Lion Investments (DBA Triton Distribution) v.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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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

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. For more information and to register, visit the program website. Also, please say hi in person or over the conference app!

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FDA Law Blog: Biosimilars

MARCH 19, 2024

Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. AMDM is known for serving as a “connector” for FDA and other regulatory bodies to share information and exchange ideas with industry. More information on the Annual Meeting can be found here.

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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. 1] However, the focus of CLIA requirements is on laboratory processes, not specific assays.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

The live webinar will dissect the proposed rule and address potential implications for the cannabis industry, state regulation, research and social justice and equity. Information and registration is available at the conference webpage here.

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FDA Law Blog: Biosimilars

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Modifications that are not consistent with the authorized PCCP, however, must be evaluated in accordance with the traditional regulatory process described in applicable regulations and guidances referenced above. See 21 CFR 807.81(a)(3)

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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Recent changes in drug approval processes, intellectual property laws, and pricing regulations have introduced both opportunities and challenges for dealmakers.

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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

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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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. It is not our purpose to describe all of the nearly 20 changes proposed in this regulation, but the most noteworthy are described below, roughly in order of importance.

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FDA Law Blog: Biosimilars

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

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FDA Law Blog: Biosimilars

OCTOBER 26, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — In our June blog post , we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. 552), there are exemptions from mandatory disclosure.

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