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Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. The rest of this blog will focus on the Clinical Trials Grants Program. By Sarah Wicks & James E. Valentine — The U.S. Relative to other areas of medicine (e.g.,
In recent years, advanced manufacturing has gained traction in the pharmaceutical industry, transforming how drugs are developed, produced, and delivered. In this blog, we explore the concept of advanced manufacturing and outline the FDA programs that play a critical role in promoting innovation while ensuring product quality.
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. 3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming.
These applications are incredibly useful for basic research, studying the environment , probing different aspects of biotechnology , or contributing to undertakings like drug discovery. Improved understanding Understanding metabolism is also crucial for drug discovery and investigating disease mechanisms.
Inhalation offers a targeted route of drug delivery directly to the lungs, minimizing systemic side effects and maximizing therapeutic benefits. Reduced side effects: ICPs can offer reduced side effects compared to individual drugs because a lower dose of each drug is often sufficient when they are combined.
When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines. When a company applies these approaches, even small or novice drug developers will see increased efficiency.
Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance).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.
Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. The Court thus explained that interpreting the patent in 35 U.S.C.
Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug quality, safety, and efficacy. Drug product (finished dosage form).
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. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?
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. Turcotte is always enthusiastic to share his knowledge and help Altasciences’ partners improve the quality of their drug development programs.
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. In regulated domains, every step must be documented, auditable and reproducible to meet stringent regulatory requirements.
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?
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.
Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. FDA has published Guidance defining examples of circumstances applicable to a drug or medical device company, as well as separate Guidance applicable to foreign food manufacturers. Walsh & Hyman, Phelps & McNamara, P.C. &
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0
Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Marijuana would also remain subject to applicable provisions of the Food, Drug and Cosmetics Act.
Food and Drug Administration (FDA). In that role, he led and supported the agency’s litigation efforts in high-stakes matters involving drug approvals, exclusivity disputes, enforcement actions, and administrative law challenges. He also provides strategic litigation support and proactive counsel on agency engagement.
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. Food & Drug Administration. Learn more References: ICH Harmonised Guideline. Final Version, January 6, 2025.
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. Download a copy of this case study. Key Steps in the Process 1.
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. first or second line setting), considering clinical, scientific, regulatory, and operational factors.
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.
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. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.
Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments. In our latest blog post, we dive into the strategies and challenges of patenting drug combinations.
What might that look like for the drug sector? This overprescribing relates to a lack of long-term data for either safety (particularly neurodevelopmental) and efficacy for drugs which are nevertheless often prescribed long-term. That leaves us to speculate what the implications of this Assessment will be.
Houck Drug Enforcement Administration (DEA) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. By Larry K. On March 26th the U.S.
The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?
The Value of Clinical Research Clinical research is the engine that drives medical innovation, leading to the discovery of new drugs, treatments and medical devices that enhance patients access to treatment options, improve patient care and outcomes, and transform the healthcare landscape.
Schwartz — Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. One occurrence where an adulterated drug leads to injury can change a lot of minds about government’s role and the extent of needed FDA oversight. Kennedy, Jr., The task before these investigators is daunting.
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.
The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? Drugs/Biologics/Devices / Tobacco (CDER, CBER, CDRH, CTP) These centers are largely supported by user-fee programs that support their review staff (MDUFA, PDUFA, BsUFA, GDUFA).
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?
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. The first point he made pertained to reforming the Prescription Drug User Fee Act (PDUFA).
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.
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.
Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. In 2021, the U.S.
Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. 105288 (Dec.
The Federal Controlled Substances Act (“CSA”) and its regulations require Drug Enforcement Administration (“DEA”) registrants to submit certain reports related to narcotic drug transactions, thefts and significant losses, and suspicious orders. 21 U.S.C. § 827(d)(1); 21 C.F.R. Code 4729:8-3-04. 16, § 1782; Ga. Code Ann. §
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.
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).
As HPM argued in both the groundbreaking citizen petition Jeffrey Gibbs filed thirty-two years ago and the papers we filed on behalf of our clients, Dr. Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices.
Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. FOIA is a U.S.
With a decade of experience as regulatory counsel in the FDAs Center for Drug Evaluation and Research Office of Scientific Investigations, her experience will help Advarras clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research. Sponsors often ask, How will the FDA view this?
Food & Drug Administrations standard for safety and efficacy. Advarra’s IRB is highly experienced and works diligently to provide expert oversight, ensuring that every clinical trial adheres to the highest ethical standards and is compliant with applicable regulations. This process ensures that new therapies meet the U.S.
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