FDA Law Blog: Biosimilars

MARCH 6, 2024

FDA Law Blog readers can use discount code S10-866-866L24.S Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. More information about the conference can be found here. S for reduced registration fees.

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FDA Law Blog: Biosimilars

NOVEMBER 10, 2024

These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development. The rest of this blog will focus on the Clinical Trials Grants Program.

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FDA Law Blog: Biosimilars

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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Drug Development 52

Express Pharma

DECEMBER 30, 2024

They offer various programs, from undergraduate degrees in pharmaceutical sciences to specialised graduate courses focusing on drug development, regulatory affairs, and market access. Universities serve as the foundational training ground for the next generation of pharmaceutical professionals.

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Pharmaceutical Companies Pharmaceutical Companies Drug Development 105

Syner-G

SEPTEMBER 15, 2023

The post Understanding Large Molecule Drug Development: From Biologics to Market appeared first on SYNER-G. By embracing technological innovations and new best practices, companies can meet the rising demand for biologics, and improve patient outcomes, and the bottom line.

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FDA Law Blog: Biosimilars

APRIL 1, 2025

While much may be in flux, the central tenet of drug development remains the same, develop drugs that are safe and effective drugs for patients, through streamlined, efficient, and cost-effective development programs. Therein lies the opportunity.

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Communication Drug Development 77

FDA Law Blog: Biosimilars

MARCH 3, 2025

FDA Law Blog is a conference media partner. Hyman, Phelps & McNamara, P.C.s As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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Drug Development 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development. Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

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Express Pharma

JANUARY 17, 2025

Carbon contributing factors: The mitigating factors throughout the drug development process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.

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Express Pharma

MARCH 2, 2025

Large Pharma companies in India have already been appointing North America focused Regulatory Affairs leadership roles, responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.

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FDA Law Blog: Biosimilars

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Pharmacy Is Right For Me

JUNE 29, 2022

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! In addition to learning more about unique pathways on our new webpage, we’ll also be featuring pharmacists who work in these unique settings on our blog.

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Pharma Marketing Network

JULY 26, 2023

In this blog post, we will explore the potential reasons behind this trend and its implications for the pharmaceutical industry and public health. Greater Pre-Approval Scrutiny: The FDA has been placing increased emphasis on reviewing and providing feedback on promotional materials before drug approvals.

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Putting Patients First Blog

NOVEMBER 21, 2024

The two-day retreat was jam-packed with opportunities for attendees to hear from policy and regulatory experts, share organizational challenges and successes, and network with peers. We look forward to building on these conversations at the 2025 Washington Representatives Retreat in Annapolis on November 20 – 21!

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Pharma Marketing Network

MARCH 13, 2025

SEO-optimized blog content helps brands rank higher in search results. Email marketing campaigns can keep healthcare professionals informed about drug developments. High-quality articles, patient testimonials, and whitepapers provide valuable information while building trust.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Putting Patients First Blog

AUGUST 15, 2024

In addition, patient experience data has also been included as part of the 21 st Century Cures Act which would assist the U.S.

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FDA Law Blog: Biosimilars

DECEMBER 13, 2023

Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development.

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Drug Development 59

FDA Law Blog: Biosimilars

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes.

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Express Pharma

AUGUST 6, 2024

One of the most promising developments has to do with the use of generative AI in drug discovery. But how precisely is GenAI speeding up the drug discovery pipeline while cutting down on development costs? That’s expected to reduce the cost by up to $300 million per successful drug brought to market.

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Marks promotion to Counsel reflects the value that he brings to the firm and his clients based on expansive and diverse experiences in the drug development arena, commented HPM Director James Valentine.

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Syner-G

OCTOBER 27, 2023

Bringing a new drug to market is a complex process that can take years with no guarantee of a successful outcome. The journey is highly regulated and includes numerous processes that require drug developers to have multiple levels of expertise within their teams. This includes skipping pre-IND meetings.

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FDA Law Blog: Biosimilars

DECEMBER 20, 2023

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. In June 2023, the list expanded to include Type B End-of-Phase 2 meetings (which we blogged about here ). And there we stayed for 6 more months, until now.

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Putting Patients First Blog

JANUARY 22, 2025

Gunnar Esiason, Senior Director, Head of Patient Engagement and Patient-Centered Innovation, at Raven (RA Ventures) will discuss the critical importance of early patient engagement in drug development from an investors perspective, highlighting the need for patient voices.

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Communication Diabetes Drug Development 52

Putting Patients First Blog

OCTOBER 31, 2024

Rare Pediatric Disease Priority Review Voucher Program Previously extended through December 20, FDA Priority Review Vouchers for rare pediatric disease are intended to incentivize drug development for rare diseases. These vouchers drive innovation and are imperative to expediating scientific breakthroughs.

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pharmaphorum

JANUARY 26, 2022

With drawn-out timelines and billions in investments, traditional clinical trial methods are increasingly a barrier to cost-efficient and timely drug development. Read Accenture’s latest INTIENT Ecosystem blog about synthetic control arms in clinical trials here.

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Drug Development 52

Pharmacy Is Right For Me

APRIL 4, 2023

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! In addition to learning more about unique pathways on-site, you can also understand more about the career paths of these pharmacists here on our blog.

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FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.

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Drug Development 59

FDA Law Blog: Biosimilars

MAY 19, 2024

Speakers at the Scientific Workshop will include Dr.

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Drug Development 59

Pharmacy Is Right For Me

JANUARY 25, 2023

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! In addition to learning more about unique pathways on our new webpage, we’ll also be featuring pharmacists who work in these unique settings on our blog.

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Definitive Healthcare

FEBRUARY 23, 2024

Resource Type E-Books & How-To Guides Blog How-To Guide Healthcare Insight Medical claims 101: What you need to know How to sell effectively to healthcare facilities and executives using the right… Hospital payor mix by state Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHover":false,"pauseOnDotsHover":false,"autoplay":false,"rows":0},"sm":{"slidesToS

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Drug Pricing Hospitals Drug Development 52

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

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Express Pharma

OCTOBER 19, 2024

Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D.

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Definitive Healthcare

JUNE 29, 2023

Resource Type E-Books & How-To Guides Blog Special Report Webinar A (friendly) ghost in the machine: Exploring AI in medical devices AI in healthcare study AI and machine learning in healthcare Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHover":false,"pauseOnDotsHover":false,"autoplay":false,"rows":0},"sm":{"slidesToShow":2,"arrows":true,"prevArrow"

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Drug Development 52

Syner-G

NOVEMBER 1, 2023

Just staying on top of the changes can present an ongoing challenge to drug developers, especially in the areas of new small molecules, biologics, cell and gene therapies, and medical devices. Other capabilities to look for include extensive experience with exploratory and creation stages of drug development.

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Drug Development Documentation 59

Fuld & Company Blog

JULY 27, 2023

A US-based healthcare company wanted to explore its options for a clinical drug development strategy that would minimize its time to market. It therefore sought to keep track of all the drug developments in its therapeutic areas to identify key industry learnings.

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Drug Development 52

FDA Law Blog: Biosimilars

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). FDA has created a DHT for Drug Development website and an email address for questions related to DHT-derived data ( dhtsfordrugdevelopment@fda.hhs.gov ).

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Drug Development 59