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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FDA Law Blog: Biosimilars

MARCH 19, 2024

Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. Mr. Gibbs’ presentation, entitled “U.S. IVD Overview and Update,” will cover recent developments in IVDs, including the proposed LDT regulation. (HP&M), the largest dedicated food and drug law firm in the U.S.,

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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. John will present on considerations and his learned perspective for the future of teleprescribing. Hyman, Phelps & McNamara, P.C.’s

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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. Hyman, Phelps & McNamara, P.C.’s s Faraz Siddiqui will speak on Tuesday, September 19, on Value-Based Agreements.

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FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, “Towards Better Speech Perception and Beyond.”

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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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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. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Author Information William E.

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FDA Law Blog: Biosimilars

SEPTEMBER 29, 2023

Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.

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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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FDA Law Blog: Biosimilars

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. The pandemic had changed the way people live, work and communicate. Such changes are not limited to personal circumstances.

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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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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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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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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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FDA Law Blog: Biosimilars

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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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

APRIL 24, 2024

The meetings have presented a mix of views with some organizations meeting with OMB being in favor of FDA regulation and others being very much opposed. With a final rule now nearly a certainty, a legal challenge seems likely to follow.

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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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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 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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FDA Law Blog: Biosimilars

JUNE 28, 2023

In September 1998, CVM published Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods With Drug Claims , which provides guidance on how CVM regulates substances for animals. On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims.

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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. The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

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Agency IQ

SEPTEMBER 22, 2023

The goal of the framework , as described in a 2019 presentation from FDA staff on the subject, is to “provide prescription drug sponsors the flexibility to disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors’ communications about their products.” This would be considered a type of drug labeling.

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FDA Law Blog: Biosimilars

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in. Be ready with backup options (e.g.,

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FDA Law Blog: Biosimilars

NOVEMBER 28, 2023

Although comments submitted after November 15 won’t be presented to the panel, FDA says it will still take them “into consideration.” We cannot recall any other situation where FDA gave stakeholders precisely two days in which to comment. The docket will remain open through December 29.

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. By Larry K. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy. at 48379 (to be codified at 21 C.F.R.

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FDA Law Blog: Biosimilars

AUGUST 8, 2023

The Guidance, which provides details about nitrosamines and FDA’s experience regulating them, explicitly applies to all finished drug products (including Rx, OTC, and unauthorized drugs), to “prescription and OTC drug products in clinical development,” and to both API and drug manufacturers.

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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

MAY 23, 2023

Specifically, field staff are advised to pay close attention to situations where allergen cross-contact may occur because of poor current good manufacturing practices (cGMPs), inadequate preventive controls, or inadequate controls under the juice or seafood HACCP regulations.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.” Carbadox has had a tortured approval history.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA regulations, at 21 C.F.R. As such, Vanda’s citizen petition stated that these approvals are “clearly erroneous under the FDCA and agency regulations and will put. Moreover, other information, such as dosing instructions and warnings, were not presented in braille. patients in harm’s way.”

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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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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar. FOOD AND DRUG ADMINISTRATION FOIA – FDA Presentation Pending 1:2023cv02325 (D.D.C.) VANDA PHARMACEUTICALS INC. VANDA PHARMACEUTICALS INC. VANDA PHARMACEUTICALS INC.

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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. It includes questions, text, logic, and prompts, and integrates databases such as FDA product codes and FDA-recognized voluntary consensus standards.

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FDA Law Blog: Biosimilars

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. We will then present an effective strategy to address FDA’s AI request in a timely manner. In this presentation, FDA suggested the following tips.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. That regulation is pretty clear. Karst — After waiting with bated breath for more than a week since posting spicy Part 1 and Part 2 of our three-part series on recent U.S. 27, 1995); aff’d , 109 F.3d

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