FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

Compliance

PPD

JULY 29, 2025

Detailed governance, oversight and management processes Dedicated hub leads ensure operational efficiency and regulatory adherence, coordinate resources, monitor performance metrics and align with sponsor goals.

Clinical Trials

PPD

DECEMBER 16, 2024

Each region presents its own set of unique and complex regulations that must be met, creating a daunting landscape for companies striving to bring their therapies to market. Although adhering to complex regulations may initially complicate trials, it serves as a critical safeguard against future roadblocks.

Drug Development

Advarra

MAY 21, 2025

With global regulators including the FDA, EMA, and MHRA signaling alignment and implementation in 2025 [FDA, 2025; EMA, 2025; MHRA, 2025], sponsors must act now to align their strategies with the new expectations. Existing SOPs, oversight models/governance, and QMS frameworks are being reassessed for readiness and relevance.

Pharma Companies

Drug Target Review

MAY 21, 2025

Blood centres already navigate complex logistical and regulatory challenges in managing the national blood supply, with biological therapies that must adhere to stringent guidelines similar to those governing CGTs. Extending these systems to support advanced therapeutics is not just logical, its practical and cost-effective.

Therapies

Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

Drugs

ACTO

DECEMBER 17, 2024

The Foundation: Governance and Security Successful AI implementation begins with strong platform governance and security standards. The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value.

Government

Codon

APRIL 17, 2025

Such vascular differences are governed by auxin, a plant hormone that regulates leaf venation and shape. The researchers also note fewer free-ending veinlets and thinner vascular networks in mimic leaves, interpreting this as evidence of active mimicry.

Research

Codon

JULY 28, 2025

The first of these components is the therapeutic genetic payload, or cargo, which is designed to correct or regulate the disease-causing mutation, whether that means offering a healthy copy of a mutated gene or delivering precision-editing tools like CRISPR. Equally vital is the delivery vector, which carries this payload to specific cells.

Immune Response

Drug Patent Watch

MARCH 4, 2025

Stay up-to-date on regulatory requirements : Familiarize yourself with the latest guidelines and regulations governing pharmacovigilance. Train your team on pharmacovigilance best practices : Ensure that everyone involved in the development process understands the importance of pharmacovigilance.

Drug Development

PPD

JUNE 17, 2025

The right FSP partner implements this structure in a way that ensures efficient governance and an optimized oversight infrastructure, thus ensuring that sponsors maximize the benefits of this model while preserving quality and compliance.

Clinical Development

Perficient: Drug Development

FEBRUARY 12, 2025

The industry faces numerous challenges, including protecting sensitive data, navigating evolving regulations, and outdated legacy systems. To harness AIs potential effectively, its essential to develop a strategy that considers payment regulations to ensure consumer protection , data privacy , and ethical use of AI.

Compliance

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. What does it mean for FDA staff?

Government

Drug Patent Watch

JANUARY 9, 2025

A: First, try to address issues through open communication and your established governance structure. Q: How can I ensure my CDMO is staying compliant with evolving regulations? If problems persist, review your contract for any performance clauses or dispute resolution procedures. A: Regular audits and open communication are key.

Compliance

FDA Law Blog: Biosimilars

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Drugs

Drug Channels

JULY 21, 2025

Join 700 annual attendees and nearly 100 expert speakers to master complex regulatory guidelines to deliver compliant government pricing and reporting programs. Fireside Chats where an expert panel of attorneys discuss the most pressing issues facing MDRP and Government Pricing.

Government

Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

Regulations

FDA Law Blog: Biosimilars

MAY 4, 2025

1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S. The government alleged that IMC Pro entered into business agreements with companies operating in China.

Packaging

FDA Law Blog: Biosimilars

AUGUST 10, 2025

which stated that IVD products are FDA-regulated devices “including when the manufacturer of these products is a laboratory.” Because the government chose not to appeal the decision vacating the LDT Final Rule, the rescission is largely a formality, as the added regulatory language is already a dead letter.

FDA

Advarra

MARCH 6, 2025

Food and Drug Administrations (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

Clinical Research

Perficient: Drug Development

MAY 28, 2025

Yet, amidst this intoxicating surge of innovation, a sobering reality looms large: the absence of robust, globally harmonized frameworks for responsible development and stringent regulation. My Perspective: The answer lies in stronger data governance and privacy-preserving AI techniques.

Government

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers. How regulators will interpret and enforce its provisions may not become clear for some time.

Clinical Trials

Codon

JULY 17, 2025

government could do until the 1938 Federal Food, Drug, and Cosmetic Act gave authority to the FDA to regulate drugs. Still, there wasn’t much the U.S. The agency promptly used its new powers to ban DNP. Other countries followed, with some classifying the chemical as a poison.

Drugs

FDA Law Blog: Biosimilars

NOVEMBER 19, 2024

But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FDA is already facing a massive inspectional backlog. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr.,

FDA

Perficient: Drug Development

NOVEMBER 19, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

Regulations

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. Wise government officials will modulate their views as they learn new facts. for Secretary of Health and Human Services (HHS).

FDA

FDA Law Blog: Biosimilars

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. The DCP should follow applicable regulations governing human subject protections, where applicable. By Adrienne R. Some disease conditions may not be as prevalent and the DCP should describe any enrichment strategies to ensure subgroups are represented.

FDA

FDA Law Blog: Biosimilars

JUNE 1, 2025

Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. By Charles D. Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. In 2021, the U.S.

Drugs

Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

Regulations

Drug Patent Watch

FEBRUARY 18, 2025

Here are a few key takeaways: Key Takeaways: Understand the regulatory landscape : Familiarize yourself with the guidelines and regulations governing clinical efficacy trials for biosimilars. So, what can biosimilar developers do to navigate these regulatory considerations and bring their products to market efficiently?

Biosimilars

The Pharma Data

JUNE 9, 2025

WHO Maintains Global Health Emergency Status for Mpox Amid 2024 Surge, Issues Strengthened Recommendations In response to the continuing resurgence of mpox across several regions in 2024, the World Health Organization (WHO) convened the fourth meeting of the International Health Regulations (2005) Emergency Committee on 5 June 2025.

Vaccine

FDA Law Blog: Biosimilars

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. HPM is keeping a watchful eye on the various indirect means by which FDA may try to regulate LDTs.

FDA

FDA Law Blog: Biosimilars

APRIL 10, 2025

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S.

FDA

Perficient: Drug Development

APRIL 15, 2025

This suggests potential sex-based differences in immune regulation following SARS-CoV-2 infection. The path forward requires collaboration across healthcare systems, research institutions, government agencies, employers, and community organizations.

Immune Response

FDA Law Blog: Biosimilars

MAY 23, 2025

Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. The Announcement raises several questions and issues for the device industry. 10-for-1 Rule and its effect on de novos. Radical Transparency.

FDA

FDA Law Blog: Drug Discovery

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

FDA

Codon

JUNE 12, 2025

government also went through a very deliberate process to make sure that it had independence and freedoms to be able to do all of the best things that early DARPA was able to do. ” It's not a great place to invest given the capital, entrenched interests, regulations, etc. Our governance permits that kind of decision-making.

Government