FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. By Jeffrey N. Gibbs & Steven J.

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

The announcement also states that FDA expects most future companion diagnostic and infectious disease IVDs would be regulated as class II devices, even if they are novel and require de novo classification. And as we note in that earlier blog , there is good reason to believe all of the above numbers are gross underestimates.

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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.

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addgene Blog

AUGUST 10, 2023

Because of its importance, scientists have developed calcium sensors to better understand how this metal ion is trafficked and regulated. In this blog we will explore some of the most commonly used as well as newly developed calcium sensors. It is an enzyme co-factor, a crosslinking agent, a signaling ion, and an allosteric modulator.

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BMG Labtech

DECEMBER 20, 2024

1-3 In this blog we examine bacterial metabolism: its scope, its interest to researchers, and how diverse applications, including those linked to metabolic control, measurement of metabolites and bacterial growth, can be determined using microplate readers. 9) and the bioluminescence arising from quorum sensing in parallel.

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FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.”

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The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. b) Exempt studies that do not require an IDE.

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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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FDA Law Blog: Biosimilars

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. The conference, held in Washington, D.C., April 4th and 5th, is an in-person and virtual event.

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NIOSH Science Blog: Drugs

OCTOBER 23, 2023

However, evidence mounted, implicating lead as the cause of many health problems (see related blog). 2] Something Needed to Change Increasing health concerns eventually led to federal regulations requiring industries 1] Symptoms of lead poisoning were especially apparent among lead miners and smelters. [2]

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. This blog post explores key issues, opportunities and strategies for health technology developers (HTDs) navigating this changing landscape.

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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.

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Common Sense for Drug Policy Blog

OCTOBER 1, 2024

New regulations governing methadone treatment for opioid use disorder go into effect in the US on October 2, 2024. As reported by the Associated Press on Sept. 20, 2024 ("US will let more people take methadone at home"):

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FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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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.

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The Premier Consulting Blog

NOVEMBER 6, 2024

In this blog, we will discuss what a combination product is, why there is a particular advantage for inhaled products, and regulatory factors that apply to CMC activities. What is a combination product? ICPs are subject to rigorous regulatory scrutiny due to their complexity.

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FDA Law Blog: Biosimilars

JUNE 26, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. PMA or 510(k)) is required. PMA or 510(k)) is required.

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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.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.

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Perficient: Drug Development

NOVEMBER 27, 2023

This blog was co-authored by Carl Aridas and Joel Thimsen. In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. Build a reliable risk management strategy using accurate estimations and predictions.

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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

BRAIN at 10: A View from the National Institute on Drug Abuse mfleming Wed, 09/25/2024 - 19:31 Nora's Blog October 1, 2024 By Nora Volkow, MD, Director, and Rita Valentino, Ph.D., Director, Division of Neuroscience and Behavior, NIDA This blog was originally posted on the The BRAIN Blog.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In this blog, our PPD FSP regulatory affairs solutions experts share lessons learned, along with tips for success. 31, 2023, under the CTD can continue to be governed by the CTD until Jan.

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FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.

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Perficient: Drug Development

MAY 30, 2024

LinkedIn | Blogs How We’re Approaching AI AI can be exciting—but it can also be intimidating, if your organization isn’t sure where to start. Mike Porter : There is both a technical point of view here as well as very specific discussions on what’s happening with trends and regulations.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. FDA Law Blog readers can receive a 10% discount off the conference registration price. Hyman, Phelps & McNamara, P.C.’s

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FDA Law Blog: Biosimilars

JULY 22, 2024

FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.

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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?

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FDA Law Blog: Biosimilars

MAY 3, 2023

Under the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here ), all final monographs (i.e., the regulations formerly found in 21 C.F.R. FDA announced that it will be taking the next step of issuing a notice to withdraw the regulations establishing final monographs in the CFR.

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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.

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FDA Law Blog: Biosimilars

AUGUST 27, 2024

This virtual three-week program is designed to give new lawyers and executives a solid foundation in the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation. FDA Law Blog readers receive a 10% discount (use FDA Law Blog promo code: D10-999-FDA25).

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FDA Law Blog: Biosimilars

SEPTEMBER 29, 2023

Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers.

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LifeSciVC

APRIL 24, 2024

For KLK5 and KLK7 as well as their endogenous regulator (LEKTI, encoded by SPINK5 ) and one of their substrates (filaggrin, FLG ) there is evidence that KLK5 and 7 up-regulation is pathogenic and down-regulation protective in epidermal barrier dysfunction (especially for Atopic Dermatitis). in the case of CFTR for Trikafta).

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FDA Law Blog: Biosimilars

SEPTEMBER 3, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — Thank you to readers of this blog. We received incredible feedback on our August 19 post analyzing the number of decision summaries that have been posted for De Novos.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

The GAO Report provides an overview of the rulemaking process for OTC hearing aids, the resulting OTC hearing aid regulatory scheme, and FDA’s interaction with other agencies when regulating OTC hearing aids. The Agency “may issue technology specific regulations and guidance as new hearing technologies are approved and cleared by FDA.”

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.

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