Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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The Pharma Data

MARCH 30, 2021

Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Source link:[link].

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Copyright © 2006-2023 Pembroke Consulting, Inc.

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Advarra

APRIL 30, 2024

A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. For example, most hospital radiology technicians are trained to perform scans for the hospital and/or PI for clinical trials based on the information in the test requisitions. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. The other part of the definition is what constitutes “health information.”

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Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Additionally, keeping sites, principal investigators (PIs), and patients informed of changes and updates can present challenges.

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Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge]. d/b/a Drug Channels Institute.

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The Pharma Data

DECEMBER 13, 2020

Conference Call Information. SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. For more information, please visit www.relaytx.com or follow us on Twitter. About RLY-1971.

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Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

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The Pharma Data

NOVEMBER 4, 2020

Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).

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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. The content and prescription information elements required by 21 C.F.R. Two licensed pharmacists must directly communicate the transfer.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

FDA did not disclose the exact date of the IND because that information is confidential. 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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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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Perficient: Drug Development

SEPTEMBER 19, 2023

More information will be available in the coming weeks. Expanded Partnerships Google Salesforce and Google are expanding their partnership to further integrate their products.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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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. In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4 sponsors, developers and manufacturers] to disseminate information about drugs and devices.”

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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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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. Read more about what the regulator plans for its database here.]

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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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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. They all as for the same type of information: U.S. An authorization letter from an appropriate representative of Boston Scientific Corporation would satisfy this Requirement for Information.

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DrugBank

AUGUST 15, 2024

This drug, approved by the FDA in 2015, targets a protein that regulates cholesterol levels in the blood, offering a novel therapeutic approach for patients who do not respond adequately to statins. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

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The Pharma Data

NOVEMBER 29, 2020

MDM2 is a key regulator of the tumor suppressor p53 and one of the most potent inhibitors of apoptosis discovered thus far. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. SUZHOU, China and ROCKVILLE, Md. ,

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Note: If a link no longer works, it is likely because OIRA has since deleted it.)

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Policy Prescription

MAY 28, 2021

That New York Times piece included the following parenthetical disclaimer: “(My company, PharmacyChecker.com, helps Americans find information on obtaining lower-cost medications from Canada and other countries, so I have a financial stake in making sure the public is informed.)” and licensed by your state board of pharmacy.”

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The Pharma Data

JANUARY 12, 2021

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company’s intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis (“Option”). .

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Drug Target Review

OCTOBER 10, 2024

By promoting partnerships between biobanks, research institutions, regulators, and industry, we can create networks for information sharing, streamline access to diseased donor material, and facilitate joint research initiatives. Furthermore, fostering cross-industry collaboration is essential.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

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The Pharma Data

MAY 14, 2021

You should do your own research and confirm the information with other sources when searching for information regarding health issues and always review the information carefully with your professional health care provider before using any of the protocols presented on this website and/or in the product sold here.

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Drug Target Review

NOVEMBER 22, 2023

These proteins in turn regulate gene expression through the activation of several transcription factors, including NF-κB. Although we haven’t released the information about the dose escalation study in pancreatic cancer, we can certainly say the combination alongside the standard of care is safe. It is converted by autotaxin into LPA.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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DrugBank

FEBRUARY 9, 2023

Read the paper Jörn Lötsch Biomedical scientist at the Goethe - University Frankfurt am Main, Germany Research Focus: Knowledge discovery by combining artificial and human intelligence for information reduction of biomedical data with a focus on data science, pain, and clinical pharmacology. Send us your research paper.

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