Advarra

JULY 26, 2022

Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act. The post CBD Research: A Dive into the Regulations of Cannabis Research appeared first on Advarra.

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Regulations Research FDA FDA Approval 97

Agency IQ

MARCH 29, 2024

BY WALKER LIVINGSTON, ESQ The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

Regulations 59

Regulations 59

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. The bill proposes to amend FDC Act § 505(b) and PHS Act § 351(a)(2) with respect to patent information submitted to FDA for Orange Book and Purple Book listing. Koblitz & Kurt R.

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FDA Biosimilars Drugs FDA Approval 105

Agency IQ

AUGUST 30, 2024

By Laura DiAngelo, MPH The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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FDA Regulations Production 52

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. Additional information, including a preliminary agenda, is available at the conference webpage here.

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Regulations FDA Production Drugs 64

Agency IQ

JULY 22, 2024

BY WALKER LIVINGSTON, ESQ On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

Regulations 59

Regulations 59

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. In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. 21 U.S.C. § 1310.06.

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Regulations Compliance Government Production 116

Agency IQ

FEBRUARY 23, 2024

BY WALKER LIVINGSTON, ESQ The Office of Information and Regulatory Affairs (OIRA) has completed its review of the Safer Communities by Chemical Accident Prevention rule that would amend some of the agency’s risk management program procedures for facilities to focus on protecting vulnerable communities.

Regulations 59

Regulations 59

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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Regulations FDA Laboratories Disease 64

Perficient: Drug Development

APRIL 22, 2024

Let’s explore why understanding perceptible information is crucial for creating accessible pedestrian crossings and how it contributes to universal design principles. Perceptible information, such as clear signage, audible signals, and tactile indicators, helps pedestrians navigate crossings safely and confidently.

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Compliance Regulations 52

Perficient: Drug Development

AUGUST 19, 2024

The vision is that all of the data can be aggregated, harmonized and used for better, faster and more informed decision making for Financial and Non Financial Risk Management. where’s my Insight”) The primary goal of data management, sourcing and aggregation effort will have to be converting data into informational insights.

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Regulations Government Marketing Compliance 109

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). RFIs must be addressed in the clinical trial information system (CTIS) within 10 calendar days for validation and 12 calendar days for assessment.

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Clinical Trials Regulations Trials Pharmaceutical Companies 52

The Premier Consulting Blog

OCTOBER 30, 2024

With extensive experience in manufacturing techniques and regulations, the CMC services team at Premier Consulting can help sponsors navigate the development of advanced manufacturing technologies. Examples of technologies which have been accepted as an ETP include 3D printing manufacturing and continuous manufacturing processes.

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FDA Regulations Pharmaceuticals Production 52

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. While helpful background, it’s not new information.

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FDA Regulations Treatment Licensing 111

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. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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Regulations Pharmaceutical Companies International Pharmaceuticals 52

Agency IQ

FEBRUARY 2, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59

Agency IQ

JANUARY 4, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59

Agency IQ

MAY 28, 2024

BY WALKER LIVINGSTON, ESQ The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). This final rule follows a proposed rule released almost exactly one year ago. Fill out the form to read the full article.

Regulations 59

Regulations 59

Agency IQ

MARCH 1, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Regulations 59

Regulations 59

thought leadership

SEPTEMBER 30, 2024

However, do you really know what a CER is and how it evolved into the modern document required for the EU MDR (Medical Device Regulation)? In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER).

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Regulations Marketing Clinical Research Research 98

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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FDA Drugs Pharmacokinetics Production 105

Agency IQ

AUGUST 2, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Regulations 59

Regulations 59

Agency IQ

MAY 31, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Regulations 59

Regulations 59

Agency IQ

MAY 3, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Regulations 59

Regulations 59

Perficient: Drug Development

NOVEMBER 1, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Regulations Compliance Production Marketing 52

FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” FDA investigators routinely share their names, titles, contact information, and, when appropriate, reasons for conducting the inspection. By Sarah Wicks & Anne K. Ask clarifying questions.

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FDA Compliance Laboratories International 111

Agency IQ

DECEMBER 1, 2023

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59

KIF1A

SEPTEMBER 23, 2023

While we usually think of this cause as KIF1A mutations, upstream regulators of motor proteins can also disrupt traffic. In a recent pre-print*, the Holzbaur Lab at University of Pennsylvania investigated how a protein called LRRK2 regulates the traffic of synaptic vesicle precursors, a type of KIF1A cargo. What’s a pre-print?

Regulations 111

Regulations Disease Science Production 111

Chemical Biology and Drug Design

JANUARY 15, 2024

The expression levels of endoplasmic reticulum (ER) stress-related protein and silent information regulator 1/nuclear factor kappa-B (Sirt1/NF-κB) signaling pathway were used to observe the therapeutic effect of naringin.

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Disease International Regulations Treatment 100

biobide

JULY 21, 2023

The gut–brain axis includes the central nervous, endocrine, and immune systems, and it is an information exchange network that connects the gut and the brain. It can transmit information bidirectionally: “top–down” from the brain to the gut and “bottom–up” from the gut to the brain.

Regulations 97

Regulations 97

FDA Law Blog: Biosimilars

MARCH 12, 2023

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. Please see detailed information in the attached flyer , including a link to register for our free webinar. Hyman, Phelps & McNamara, P.C.’s We hope you join us!

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Regulations Government FDA Drugs 98

FDA Law Blog: Biosimilars

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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FDA Biosimilars Production Marketing 104

Chemical Biology and Drug Design

APRIL 1, 2023

Berberine has been shown in in vitro and in vivo studies to inhibit various types of cancer by activating the p-53 and cyclin-B expression, targeting various cell signalling pathways, to regulate the cell cycle. It also inhibits the invasion and metastasis of cancer cells.

Therapies 100

Therapies RNA Regulations Research 100

Agency IQ

AUGUST 30, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars and meetings. Fill out the form to read the full article.

Regulations 52

Regulations 52

FDA Law Blog: Biosimilars

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

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FDA Regulations Marketing Drugs 105

Perficient: Drug Development

FEBRUARY 29, 2024

Geo-coding data with tags to comply with European regulations is also a possible target of opportunity. Compliance and Regulation This is related to, and can be used in conjunction with, data classification and security. In an increasing regulated data environment, it pays to make your data assets easy to regulate.

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Government Regulations Compliance Marketing 78

Chemical Biology and Drug Design

JANUARY 29, 2024

the yeast silent information regulator 2 (sir2) protein) in 2000, more and more sirtuin proteins have been identified and are currently known to be present in organisms from all the three kingdoms of life (i.e., Abstract Since the discovery of the sirtuin family founding member (i.e., bacteria, archaea, and eukarya).

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Regulations Research 100