Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

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Compliance Regulations Licensing Licensing 52

FDA Law Blog: Biosimilars

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals.

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Perficient: Drug Development

MARCH 5, 2024

Assigning the Right License Access to objects is determined based on the license type, such as High-Volume Customer Community, Customer Community Plus, and Partner Community. Therefore, profiles can be employed to regulate access to objects, fields, and other elements.

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Licensing Licensing International Regulations 59

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies.

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Therapies FDA FDA Approval Treatment 119

Policy Prescription

MAY 28, 2021

PSM actively lobbies against them – but this blog post is not about that. and licensed by your state board of pharmacy.” state-licensed board of pharmacy licensed pharmacy.”. Licensed Canadian retail pharmacies cannot dispense medications in person or through the mail that are not approved for sale in Canada.

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Pharmacy Licensing Licensing Online Pharmacies 52

Advarra

APRIL 30, 2024

This blog outlines what to look out for when preparing your investigator site files (ISF) for an audit. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. The FDA 1572 Form, CV, financial disclosure form, and medical license should all show consistency regarding the PI’s name.

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Licensing Licensing Pharmacy FDA 52

FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. It is not our purpose to describe all of the nearly 20 changes proposed in this regulation, but the most noteworthy are described below, roughly in order of importance.

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Drugs Regulations Vaccine Government 59

National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

A new roadmap for cannabis and cannabis policy research mfleming Fri, 01/03/2025 - 11:38 Nora's Blog January 14, 2025 Image Getty Images/ Fiordaliso The greatly increased availability of cannabis over the last two decades has outpaced our understanding of the public-health impacts of the drug.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). If the drug were legally marketed, the considerations may be different, and therefore CVM recommends that these sponsors “obtain an index listing, approval, or conditional approval.”

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Drugs FDA Licensing Licensing 59

The Premier Consulting Blog

NOVEMBER 8, 2022

This blog post aims to bring clarity to this confusing subject for sponsors. e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g.,

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Production Efficacy & Potency Packaging Drugs 52

The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. Note that pre-approval inspections for biologics are referred to as pre-licensing inspections (PLI).

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Small Molecule Drugs FDA Production 52

FDA Law Blog: Drug Discovery

MARCH 13, 2023

This meeting will host a panel of rare disease patients, caregivers, and advocates to have a focused discussion on the emerging field of gene therapy (regulated at the FDA by OTP). The meeting will take place virtually on April 13, 2023, from 11:00 AM to 3:00 PM ET.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. FDA explained that its bioequivalence regulations at 21 C.F.R.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

While the Federal Food, Drug & Cosmetic Act does not explicitly define “advertisement,” FDA provides several examples in its regulations at 21 CFR § 201.1(l)(1) l)(1) (e.g.,

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Biosimilars Production FDA Licensing 59

Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products. and abroad.

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Regulations Science Production Vaccine 40

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect.

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Production FDA Licensing Licensing 59

FDA Law Blog: Biosimilars

AUGUST 9, 2023

DEA has amended its regulations to allow, upon request from a patient, the transfer of an EPCS between retail pharmacies for initial filling on a one-time basis only. Two licensed pharmacists must directly communicate the transfer. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy.

Pharmacy 52

Pharmacy Regulations Licensing Licensing 52

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA regulations also establish that “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” By Larry K. 21 C.F.R. §§ 1306.04(a), a), 1306.06. Code § 64B16-27.800(1), (2).

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Pharmacy Drugs Regulations Licensing 52

The Premier Consulting Blog

NOVEMBER 16, 2022

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs.

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The Pharma Data

DECEMBER 20, 2020

Services will include the production and publication of investor bulletins, distribution of investor bulletins to the Consultant’s e-mail list, and posts via the Consultant’s blogs and social media accounts. In consideration of these services, the Company has paid the Consultant a fee of US$50,000 for a 6-month contract.

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Production Clinical Trials Licensing Licensing 52

Perficient: Drug Development

NOVEMBER 22, 2023

Introduction In this blog post, we will explore the benefits of Sitecore and Azure AD B2C integration and how its advanced authentication and authorization capabilities can help businesses provide a more secure and personalized digital experience for their customers.

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Compliance Regulations Licensing Licensing 52

New Drug Approvals

OCTOBER 24, 2023

AS ON DEC2021 3,491,869 VIEWS ON BLOG WORLDREACH AVAILABLEFOR YOUR ADVERTISEMENT join me on Linkedin Anthony Melvin Crasto Ph.D – India | LinkedIn join me on Researchgate RESEARCHGATE join me on Facebook Anthony Melvin Crasto Dr. | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.

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FDA FDA Approval International Pharmacokinetics 57

Codon

APRIL 2, 2023

Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms.

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DNA RNA Engineering Licensing 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS also intends to implement a compliance monitoring program through future regulations or guidance. CMS may similarly audit participating manufacturers up to once a year to monitor their compliance after a similar 60-day notice of a reasonable basis for the audit.

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Most have focused on patents specifically licensed to pharmaceutical companies from academic institutions, where the vast majority of basic biological research takes place in America, most of it supported by NIH. The term NME refers to molecules that are unique among regulated or approved drug products in their mode of activity.

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Research Science FDA Pharmaceutical Companies 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Manufacturers who hold a biological license should report manufacturing deviations to the FDA per 21 CFR 600.14.

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New Drug Approvals

DECEMBER 16, 2023

1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. 2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. 1 H NMR (400 MHz, methanol-d4) δ 10.73 (s, 1H), 8.23 (d, J = 8.2 Hz, 2H), 7.74 (d, J = 8.3

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FDA Small Molecule FDA Approval Treatment 62

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

OASH concluded that “there is widespread current experience with medical use of marijuana in the United States” by the licensed healthcare providers for which “such medical use is recognized by entities that regulate the practice of medicine” in these states.

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FDA FDA Approval Treatment Drugs 69

Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Let me know if it works for you!

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Let me know if it works for you!

Therapies 52

Therapies RNA DNA Engineering 52