FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY.

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. Most of FDAs reviewers are exempt, while compliance, policy, and administrative support are typically furloughed. What does it mean for FDA staff?

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FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M.

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Drug Channels

OCTOBER 7, 2024

How can I ensure compliance with ERISA requirements? What can be learned from the economic landscape of biosimilars and specialty therapeutics? What is the best way to design and optimize benefits for covering GLP-1s? What are the latest developments in copay maximizer and accumulator programs? And much more !

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FDA Law Blog: Biosimilars

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. By Steven J. 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.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

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Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

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The Pharma Data

NOVEMBER 23, 2020

have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China. is an attempt on international collaboration of biosimilar medicines. and Alvotech & CCHT Biopharmaceutical Co.,

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Drug Channels

JULY 11, 2022

President and CEO, National Pharmaceutical Council Julie Ritchie Wagner, Senior Assistant General Counsel, Head of Global Ethics, Compliance, and Enforcement Legal Policy, PhRMA Joel White, Founder and President, Horizon Government Affairs Charlene Keller Fullmer, Assistant U.S. O’Brien, Pharm.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months.

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The Pharma Data

JUNE 6, 2025

From providing KOL (Key Opinion Leader) engagement personnel to facilitating local regulatory compliance, CSOs serve as essential partners in ensuring the commercial success of pharmaceutical assets across varied healthcare environments. Equally important is regulatory compliance.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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Drug Channels

JUNE 5, 2023

Two Dedicated Tracks for Your Focus Area : This Summit includes tailored content on specialty network design and patient services to customize the learning experience as well as shared content to maximize collaboration and knowledge-sharing View the detailed online agenda and register today.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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The Pharma Data

APRIL 19, 2022

We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Teva Pharmaceutical Industries Ltd. NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Pharmacies and distributors should be aware of the noncompliant activity alleged in these cases and tailor their own compliance programs to include at least some of the requirements imposed by the courts. This post examines the Zarzamora pharmacy and prescribing red flags decision. Consent Agreement and Final Judgment ¶ 10.a.-n.

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FDA Law Blog: Biosimilars

MAY 15, 2025

FDA Law Blog readers are offered a discount of 10% off the registration price. The discount code is 25HYMAN10. You can access conference information and register for the event here.

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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

FEBRUARY 9, 2024

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

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FDA Law Blog: Biosimilars

JULY 2, 2025

These fees are critical for funding FDA’s ability to review monographs, inspect facilities, and enforce compliance. Arrears List 2025: A Red Flag for Industry Compliance In June 2025, FDA’s Division of User Fee Management published a 70-page OMUFA Facility Arrears List covering fiscal years 2021 through 2025.

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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.

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FDA Law Blog: Biosimilars

JANUARY 8, 2024

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. Having the right diligence team is critical because proper risk assessment of regulatory risk requires a broad range of expertise.

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FDA Law Blog: Biosimilars

MARCH 21, 2024

Although much remains to be decided and industry is waiting for guidance from FDA related to some of these issues such as serious adverse event reporting, conference discussions all embraced the development of an appropriate internal company infrastructure to handle new requirements as part of a good faith display of compliance. By John W.M.

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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

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

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

MARCH 30, 2023

The first day is dedicated to manufacturers, while Days 2 and 3 are for regulatory compliance personnel and mid-level to senior managers. DEA will offer virtual accessibility to those who cannot attend in person. Relevant information and links follow. Click here to VIEW AGENDA.

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FDA Law Blog: Biosimilars

APRIL 6, 2025

Andrew Hull brings his expertise to the firms enforcement, compliance, and litigation practice. She also has extensive experience in advisory committee preparation, authored numerous Guidances for Industry, and co-developed the current drug review process and template. Director Karla L. Palmer, commented.

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Conversations in Drug Development Trends

JULY 9, 2024

Challenges in GLP-1 Medication Usage Despite the emerging therapeutic benefits of GLP-1 medications, these treatments also face several challenges, including: Patient Compliance Due to Side Effects One considerable challenge of GLP-1 treatments is their administration method, which is typically a daily injection.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. Most of the compliance dates have been passed.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date.

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FDA Law Blog: Biosimilars

APRIL 12, 2023

Register here !

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh has garnered acclaim for her passionate efforts in assisting companies with preventing or responding to government investigations, conducting internal investigations to ensure compliance, and defending against DOJ prosecutions. Prior to her tenure at Hyman, Phelps & McNamara, Ms.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

Some of the other (but not all…) topics of interest at this day-long conference presented by US and Puerto Rico industry thought leaders include: Experiences and Challenges of Puerto Rico State Licensing Internal Investigations: Monitoring, Compliance, Enforcement Actions The State of the Pharmaceutical Industry in Puerto Rico Navigating Global Turbulence: (..)

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FDA Law Blog: Biosimilars

APRIL 8, 2024

From that lack of detail, it would appear that FDA thinks of Good Manufacturing Practice (cGMP) compliance as a timeless and ecumenical pursuit, following the well-worn path laid out in its now-18 year old guidance. The role of technology on quality was another feature.

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FDA Law Blog: Biosimilars

MARCH 29, 2024

In December, Commissioner Robert Califf wrote about the importance of transparency in trials , noting the FDA takes a risk-based approach to compliance and enforcement. The report comes at a time when FDA is trying to map out how it wants to exercise the authority it has over clinical trials. The stakes remain high, though.

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