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New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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

Biosimilars 40

Biosimilars FDA Production Licensing 40

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.,

Biosimilars 40

Biosimilars Pharmaceuticals Pharmaceutical Companies Marketing 40

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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FDA Compliance Clinical Trials Drugs 105

Drug Patent Watch

DECEMBER 12, 2024

Case Study 2: Novel Formulation of Existing Drug A biotech firm discovered a branded drug with a novel formulation that significantly improved patient compliance. Biosimilars and Complex Generics The rise of biosimilars and complex generics is changing the dynamics of market exclusivity.

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Licensing Licensing Biosimilars Drugs 90

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The settlement agreement states that the government took into account eBay’s compliance investments, implying that eBay was given some credit that may have reduced the amount of the fine. Also, DEA and DOJ contend, eBay did not verify purchaser’s identification as required by the regulations.

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Regulations Compliance Government Production 116

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 !

Pharmacy 74

Pharmacy Biosimilars Compliance Marketing 74

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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Compliance FDA FDA Approval Drugs 52

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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Specialty Pharmacies Pharmacy Biosimilars Compliance 83

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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Compliance FDA Drugs Pharmaceuticals 97

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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Pharmaceutical Companies Compliance Biosimilars Pharmaceuticals 52

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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Compliance Drugs Pharmacy Licensing 105

DrugBank

AUGUST 9, 2024

Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI. When a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug.

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Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 77

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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Pharmacy Government Treatment Compliance 139

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 Compliance Regulations Engineering 105

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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Compliance FDA Regulations Government 59

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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Specialty Pharmacies Pharmacy Biosimilars Compliance 55

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 Compliance Regulations Government 69

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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Production Compliance Regulations FDA 64

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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Hospitals Nurses Compliance Pharmacy 59

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 FDA Approval Biosimilars Regulations 52

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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Laboratories Compliance FDA Regulations 59

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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Marketing Compliance Science FDA 59

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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Compliance FDA Government Regulations 52

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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Clinical Trials Trials Clinical Research Compliance 52

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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Compliance Drugs 59

FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

Non-compliant facilities face: Increased patient and employee health risks — in some cases even overdose deaths Multi-million-dollar settlements — and these amounts have been increasing each year Significant long-term compliance costs to meet the requirements of government settlement agreements Erosion of public trust and confidence in affected hospitals (..)

Hospitals 49

Hospitals Pharmacy Compliance Government 49

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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Clinical Research Treatment Research Clinical Trials 52

Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By revenue, the largest CRO in the US was Thermo Fisher Scientific Inc., of total revenue).

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Clinical Trials Clinical Research Trials Laboratories 52

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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Small Molecule Government FDA Approval Regulations 102

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 Compliance Government International 59

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: (..)

Pharmaceuticals 59

Pharmaceuticals Compliance Licensing Licensing 59

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

Non-compliant facilities face: Increased patient and employee health risks — in some cases even overdose deaths Multi-million-dollar settlements — and these amounts have been increasing each year Significant long-term compliance costs to meet the requirements of government settlement agreements Erosion of public trust and confidence in affected hospitals (..)

Hospitals 45

Hospitals Pharmacy Compliance Government 45

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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Packaging Compliance FDA Production 45

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 Compliance Pharmaceuticals Drugs 59

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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Clinical Research FDA Research Clinical Trials 59

FDA Law Blog: Biosimilars

APRIL 12, 2023

Register here !

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FDA Compliance Science Production 52

FDA Law Blog: Biosimilars

JANUARY 15, 2024

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 originally set the PMTA deadline as August 8, 2022, but a district court in Maryland ordered FDA to shorten it.

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