Drug Patent Watch

APRIL 14, 2025

"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies.

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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Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance).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.

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The Premier Consulting Blog

OCTOBER 30, 2024

In recent years, advanced manufacturing has gained traction in the pharmaceutical industry, transforming how drugs are developed, produced, and delivered. It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies.

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PPD

JULY 18, 2025

This blog reviews six of the most valuable aspects of regulatory communication and relationship building that, when executed properly, are often able to enhance a therapy’s chance of getting to market. When a company applies these approaches, even small or novice drug developers will see increased efficiency.

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Alta Sciences

JULY 18, 2025

Get in touch with us or one of our colleagues to see how our innovative solutions can speed up your drug development process. As a scientist, he is responsible for assay development and supporting regulated scientists for a smooth transition of the methods to a validated state. Ready to advance your next project?

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PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

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The Premier Consulting Blog

JANUARY 14, 2025

Established in 2017 under the 21st Century Cures Act, the OCE brings together multidisciplinary scientific expertise to accelerate the review and approval of drugs, biologics, and medical devices for cancer care. Provides the Oncology Dosing Toolkit.

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FDA Law Blog: Biosimilars

APRIL 1, 2025

By Dr. Naomi Lowy, Principal Drug Regulatory Expert Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails. Just as important will be the need to respond expertly, efficiently and meaningfully to FDA concerns. Therein lies the opportunity.

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PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. Accelerate your clinical research with our drug development digital solutions from Thermo Fisher Scientific.

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LifeSciVC

JUNE 12, 2025

This ability to activate pathways could be possible for almost all proteins, however the biggest differentiation was to consider areas that were hard to drug – transcription factors, ion channels, intracellular proteins, etc. Is it more important to have a clinical meaningful drug candidate OR convenience?

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ACTO

DECEMBER 17, 2024

Part 2 Our first blog covered the ABCs of Artificial Intelligence (AI) and AIs evolution. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The stakes for AI adoption in the pharmaceutical industry have never been higher.

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Alta Sciences

APRIL 24, 2025

Altasciences Preclinical Approaches to GLP-1 RA Development Preclinical studies for first generation GLP-1 RA therapeutics for treatment of diabetes have generally been standard GLP studies, conducted with normal-weight animal models. This blog was originally published in April 2025. Get in touch today to get started with Altasciences.

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FDA Law Blog: Drug Discovery

DECEMBER 23, 2024

As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended. The first sunset date is the authority to grant a priority review voucher to a rare pediatric disease product application for a drug that has not been designated as a drug for a rare pediatric disease.

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The Premier Consulting Blog

DECEMBER 16, 2024

New drug development is a long and expensive process that can be fraught with obstacles, including unexpected delays, poor efficacy results, safety issues, or regulatory challenges. The need for difficult decisions The latest estimates on the median cost of bringing a new drug to market is now $2.3

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FDA Law Blog: Drug Discovery

APRIL 20, 2025

By Dr. Naomi Lowy, Principal Drug Regulatory Expert & James E. This rings particularly true amongst the rare disease patient community, along with many small biotech companies (and their investors) that take on the risk of developing orphan drugs for exceedingly small patient populations.

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FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers. We also note that the statute (at 21 U.S.C. This is, understandably, a difficult situation for sponsors.

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Alta Sciences

JUNE 26, 2025

MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Salt Lake City Salt Lake City Share this page Submitted by pmjackson on Thu, 06/26/2025 - 15:11 Image Downtown (..)

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Perficient: Drug Development

DECEMBER 30, 2024

This blog post will serve as a comprehensive introduction to Generative AI, guiding you through its foundational concepts and exploring the groundbreaking features of ChatGPT. Drug Discovery: Designing novel drug molecules. Example: Imagine you’re writing a blog post about the benefits of meditation.

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Production Drugs Research 52

Alta Sciences

JUNE 26, 2025

MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Gretchen Green Gretchen Green Share this page Submitted by pmjackson on Thu, 06/26/2025 - 15:12 Image gretchen-green.jpg (..)

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Pharmacokinetics Testimonials Biosimilars Drug Development 40

FDA Law Blog: Drug Discovery

MARCH 3, 2025

From funding innovations and AI in drug discovery to navigating legal and compliance challenges, this conference will provide you with the opportunity to gain the insights you need to drive scientific advancements to global market success. FDA Law Blog is a conference media partner. Hyman, Phelps & McNamara, P.C.s

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

All the while, this efficiency in clinical development requires accelerating CMC by having early-stage studies serve as large stage studies. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). By Julie Kim & Deborah L. No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Drug Patent Watch

APRIL 24, 2025

"Warning: Are You About to Fall into the Generic Drug Development Trap? As a seasoned pharma professional, I've seen it time and time again: promising generic drug candidates that fail to deliver due to avoidable pitfalls. Don't let this happen to you. " #GenericDrugs #Pharma #RegulatoryCompliance

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FDA Law Blog: Biosimilars

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP). 314.150(c).

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

Valentine We recently published the first part of our review of FDAs draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. By Richard A. Lewis, Senior Regulatory Device & Biologics Expert & James E. Questions and Answers Guidance (see previous coverage here ).

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Therapies FDA Clinical Development Production 52

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).

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FDA Law Blog: Drug Discovery

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Addressing unmet public health needs.

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Codon

JULY 14, 2025

This history of one of the world’s most widely consumed classes of drugs demonstrates the difficulties that surround the fact-finding of its origins. Firstly, the stories stretch back millennia, and secondly, aspirin is such a successful drug that there is ample material to work with.

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Perficient: Drug Development

FEBRUARY 11, 2025

This blog post explores the importance of screen reader compatibility in pharmacies, provides practical examples, and discusses why it matters for drug companies’ web pages and mobile applications. This blog series will cover various disabilities in detail, offering practical solutions and insights.

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Perficient: Drug Development

FEBRUARY 11, 2025

Why Drug Companies’ Web Pages and Mobile Applications Should Be Accessible for Screen Reader Users In today’s digital landscape, ensuring that online platforms are accessible to everyone is not just a legal requirement, but also a moral imperative. This enhances the usability of the digital platform.

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FDA Law Blog: Biosimilars

APRIL 6, 2025

Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. Andrew Hull brings his expertise to the firms enforcement, compliance, and litigation practice.

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Conversations in Drug Development Trends

MAY 15, 2025

The Investigational New Drug (IND) application is a pivotal step in the drug development journey, offering a multitude of strategic advantages and enhanced opportunities. Have you considered the multiple associated benefits and implications in the context of your novel drug development plan?

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Alta Sciences

JULY 3, 2025

MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution Business Leaders (..)

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Collaborative Drug

AUGUST 1, 2023

Streamlining Collaborations and Drug Development using CDD Vault and ELN

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