FDA Law Blog: Drug Discovery

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials. Tobolowsky & Charles G. Raver & James E.

FDA

The Premier Consulting Blog

DECEMBER 10, 2024

In this blog, we demystify the CMC section of NDA preparation , providing insights and guidance for navigating this intricate landscape. Complying with global regulations. Strategies for successful CMC preparation Cross-functional collaboration and early communication with regulators are essential for successful CMC preparation.

Marketing

Alta Sciences

JULY 23, 2025

With our deep expertise in regulated cellular analysis, our team ensures that every step—from sample collection and processing to transport and analysis—is optimized for precision and speed. Connect with Martin Turcotte on LinkedIn. This blog was originally posted in July 2025. Image blog-thumbnail-martin-turcotte-cyto-2025.jpg

International

Alta Sciences

JULY 18, 2025

As a scientist, he is responsible for assay development and supporting regulated scientists for a smooth transition of the methods to a validated state. Image blog-asms-2025-jf-larocque-benjamin-charron.jpg Synopsis Jean-François (Principal Scientist, MS) and Benjamin (Scientist 1, MD) share key takeaways from attending ASMS 2025.

Assay Development

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 8, 2025

This blog explores the core tensions between generative AI’s potential and the regulatory realities of health care and clinical research. In regulated domains, every step must be documented, auditable and reproducible to meet stringent regulatory requirements. But the stakes are uniquely high.

Clinical Research

PPD

JANUARY 2, 2025

This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

Clinical Development

FDA Law Blog: Biosimilars

JULY 27, 2025

Under the Controlled Substances Act and DEA’s implementing regulations, proceedings to deny, revoke, or suspend a DEA registration must be conducted pursuant to the hearing procedures delineated in the Administrative Procedure Act as set forth in 5 U.S.C. §§ 551-559. See 21 U.S.C. 824(c)(4); 21 C.F.R. 21 C.F.R. §§ 1316.42(f); f); 1316.52.

Regulations

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.

Pharma Companies

FDA Law Blog: Biosimilars

MARCH 24, 2025

Marijuana down-rescheduled to schedule III would still be regulated for legitimate medical, scientific and industrial use. Requirements will vary depending on the registered business activity. Schedules of Controlled Substances, 44,621. Marijuana would also remain subject to applicable provisions of the Food, Drug and Cosmetics Act.

Regulations

The Premier Consulting Blog

APRIL 13, 2025

We remain ingrained in the regulations to ensure sponsors can optimize their programs and leverage the benefits that might be available to them via new initiatives. Premier is committed to monitoring this evolving regulatory landscape to support sponsors through the design and conduct of their nonclinical programs under this new paradigm.

Animal Testing

Alta Sciences

NOVEMBER 4, 2024

This blog explores the process required for manufacturing a highly potent API for an ophthalmic indication, based on a case study involving loteprednol etabonate, a topical corticosteroid used to treat eye inflammations. When handling loteprednol etabonate, additional containment strategies were applied to reduce aerosolization.

Engineering

FDA Law Blog: Biosimilars

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Much of the debate on this issue centers on whether FDA can take photographs during an inspection (see our previous blog post ). Now, guidances are generally not legally binding, unlike statutes or regulations.

FDA

FDA Law Blog: Biosimilars

JULY 23, 2025

Pete’s in-depth knowledge of FDA’s internal processes and priorities enhances his ability to advise pharmaceutical, biotech, and other FDA-regulated companies on regulatory compliance, product development, and enforcement risk. He also provides strategic litigation support and proactive counsel on agency engagement.

Government

ACTO

DECEMBER 17, 2024

Part 2 Our first blog covered the ABCs of Artificial Intelligence (AI) and AIs evolution. 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

The Premier Consulting Blog

JANUARY 14, 2025

In this blog, we outline how the OCE gets involved in product reviews and offer a high-level summary of the programs and resources available for guiding oncology product development. Determining a new products pathway The OCE does not receive regulatory applications directly from sponsors who are developing new cancer therapies.

Clinical Trials

Advarra

JULY 3, 2025

While the latest revision marks progress in advancing transparency and scientific rigor, it also demands a thorough reassessment of research practices to ensure adherence to new regulations. If you find yourself uncertain about any of these areas, now is the time to prepare.

Compliance

Conversations in Drug Development Trends

OCTOBER 29, 2024

Through relationship-building and increased engagement, regulators aim to improve their understanding of the ‘lived experience’ of patients with rare diseases and hear their top concerns. Discover more about this industry shift in our blog.

Clinical Research

Perficient: Drug Development

FEBRUARY 26, 2025

This series of blog posts will cover main areas of activity for your marketing, product and UX teams in advance of, during and after site migration to a new digital experience platform. From business goals and priorities, page views, conversion rate, SEO considerations and marketing campaigns, to compliance and regulations.

Marketing

FDA Law Blog: Biosimilars

JUNE 4, 2025

Notably, many of the issues regarding drugs are typically considered the practice of medicine, which FDA does not regulate. That leaves us to speculate what the implications of this Assessment will be. However, that does not mean FDA is has no tools to address what the Assessment refers to as the Overmedicalization of Our Kids.

Drugs

Drug Patent Watch

FEBRUARY 26, 2025

In our latest blog post, we dive into the strategies and challenges of patenting drug combinations. The Patent Landscape: A Complex Web of Rules and Regulations When it comes to patenting drug combinations, the patent landscape is a complex web of rules and regulations. But, what are the key considerations to keep in mind?

Drugs

FDA Law Blog: Biosimilars

NOVEMBER 14, 2024

Department of Agriculture,” which “have become sock puppets for the industries that they’re supposed to regulate.” The first order of business will be to “clean up the public health agencies like CDC, NIH, FDA, and the U.S. Undoubtedly, the public health and economic toll of chronic disease is staggering.

FDA

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. First, regulated chemicals are DEAs other controlled substances and may require registration, recordkeeping and reporting. of 1-BOC-Piperidone and 138.66 of (2-Bromethyl) benzene.

Packaging

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. We need clear regulations on data acquisition and usage for AI training, mirroring and perhaps even exceeding current data protection laws like GDPR.

Government

Perficient: Drug Development

DECEMBER 4, 2024

This blog covers key practices, advantages, disadvantages, real-world examples, and coding snippets to help you secure Salesforce integrations effectively. Securing these touchpoints ensures data integrity, confidentiality, and compliance with regulations like GDPR and HIPAA. Share your experience in the comments below!

Compliance

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 ensures that clinical trials comply with the U.S.

Clinical Research

FDA Law Blog: Biosimilars

NOVEMBER 19, 2024

Schwartz — Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr., the current nominee to lead the department of Health and Human Services.

FDA

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

How regulators will interpret and enforce its provisions may not become clear for some time. By integrating modern trial methodologies and technologies, it provides a framework for conducting clinical research more efficiently while maintaining the highest standards of ethics, data integrity, and patient safety.

Clinical Trials

BMG Labtech

DECEMBER 20, 2024

In this blog, we examine the utility of absorbance and optical density measurements, including examples where microplate readers can help. Further tips on how to select the best method are described in the BMG LABTECH blog Protein measurement: find a suitable method. But how do they relate to each other?

DNA

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. Gibbs — On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr.,

FDA

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? While the political process plays out many FDA employees will be furloughed and told to not report for duty.

Government

Drug Patent Watch

FEBRUARY 19, 2025

Quality Assurance is a team effort : From manufacturers to regulators, QA professionals, and beyond, everyone plays a critical role in ensuring the quality and safety of generic drugs. To learn more about the role of Quality Assurance in generic drugs, check out our latest blog post: [link] Share your thoughts in the comments below!

Drugs

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage.

Therapies

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

NOVEMBER 6, 2024

Smaller companies, however, may have requests from board members and investors to provide confirmation from FDA that their approach to product regulation is correct and in alignment with FDA requirements. The question is how best to go about doing so. Some companies will submit 513(g) requests. Others submit pre-submissions.

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.

Pharmaceutical Companies

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The conference equips legal professionals without prior regulatory experience, as well as life sciences executives involved with FDA-regulated products, with a comprehensive understanding of fundamental FDA principles. This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products.

FDA