Drug Patent Watch

NOVEMBER 20, 2024

Generic drug development is a complex process that involves rigorous scientific research and regulatory assessments. Food and Drug Administration (FDA) plays a crucial role in ensuring the quality and efficacy of generic drugs through various programs and guidelines.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Quanticate

AUGUST 2, 2024

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences.

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Drug Patent Watch

OCTOBER 14, 2024

Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy.

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Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). References FDA-NIH Biomarker Working Group. Clinical Pharmacology and Therapeutics. 113:9861002.

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Fierce BioTech

MARCH 31, 2025

| Project Optimus is changing the landscape of oncology drug development by redefining dose optimization standards. Learn how sponsors can align with FDA expectations and implement more precise dose-finding strategies. Watch the full interview with Alex MacDonald now!

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ProRelix Research

DECEMBER 15, 2021

­­Drug development strategy for US FDA It takes a staggering 12 years on an average for a drug to travel from the laboratory bench to your bedside! The post Drug development strategy for US FDA appeared first on ProRelix Research. This is coupled […].

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FDA Law Blog: Drug Discovery

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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DS in Pharmatics

MARCH 22, 2024

The FDA Fast Track and Accelerated Approval pathways can expedite the review of new drugs. It is important to understand these pathways and how they impact drug development, as well as other industries, like healthcare and pharmaceutics.

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Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. It also means sponsors are less likely to waste time and resources developing programs that don’t work for patients.”

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thought leadership

APRIL 18, 2025

Explore how FDA layoffs affecting the OGDP may impact generic development & how experienced regulatory consultants can help you stay on track.

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The Pharma Data

MAY 5, 2021

FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. Lei Zhang, the deputy director for the office of research and standards in OGD, said that in FY 2020, FDA issued a record high number of new and revised PSGs totaling 258.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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SCIENMAG: Medicine & Health

OCTOBER 31, 2023

— A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys.

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thought leadership

JULY 16, 2024

The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a critical component of an IND submission and is integral to US regulatory applications.

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thought leadership

DECEMBER 18, 2024

On November 27,2024, FDA released a draft guidance intended to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the in vitro bacterial reverse mutation (Ames) test of a drug (active ingredient) or its metabolites and to provide recommendations on follow-up in vitro and (..)

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Alta Sciences

MARCH 4, 2025

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. This was in 2006, at a time when the FDA guidances on these topics had not yet been published.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Rigorous procedures to ensure that drugs are effective and safe. Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. No matter how small, any lack of efficiency can snowball into costly delays in drug approval.

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Fierce BioTech

NOVEMBER 13, 2024

| Discover how minimal residual disease (MRD) assessment is accelerating multiple myeloma drug development through FDA's latest guidance.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

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PLOS: DNA Science

MARCH 28, 2024

A new drug has entered the arsenal against Duchenne muscular dystrophy (DMD), a genetic disease that affects boys and is challenging to treat. FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. seconds for patients receiving Duvyzat compared to 3.03

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DS in Pharmatics

APRIL 4, 2025

For early-stage drug developers, engaging with the FDA at the right time can be critical to success. This meeting provides early-stage guidance from the FDAs Center for Biologics Evaluation and Research (CBER) and Center []

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. The Role of Regulatory Agencies Regulatory agencies such as the U.S.

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FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization.

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Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective cost and timeline reductions of NME & NCE electronic submissions are most likely achieved via proactive, early utilization of Drug Development Services, 505(b) NDA , IND Consulting , NDA Consulting , BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA and Regulatory Body Clearance/Approval.

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H1 Blog

JULY 30, 2024

Diversity Action Plans (DAPs) aim to improve data that the FDA receives by increasing the clinical enrollment of historically underrepresented participants. The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research. billion and taking upwards of 15 years.

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The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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thought leadership

JULY 9, 2024

What is the Animal Rule?

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Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval.

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Broad Institute

JULY 17, 2024

Srijit Seal, a visiting scholar at the Carpenter-Singh Lab in the Broad's Imaging Platform , trained multiple predictive machine learning models to identify chemical and structural drug features likely to cause toxic effects in humans. Improved detection of drug-induced liver injury by integrating predicted in vivo and in vitro data.

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thought leadership

JULY 26, 2023

Food and Drug Administration (FDA) recently issued a draft guidance on the development of psychedelic drugs. There has been a growing interest in using psychedelics for the treatment of medical conditions in recent years, and this guidance by the FDA is timely to support researchers investigating this use.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Agency IQ

JULY 22, 2024

BY LAURA DIANGELO, MPH In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs).

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FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. FDA Law Blog readers can use discount code S10-866-866L24.S S for reduced registration fees.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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