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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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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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). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.

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Agency IQ

SEPTEMBER 22, 2023

The FDA regulates both product labeling ( 21 CFR 201 ) and promotional labeling ( 21 CFR 202 ). FDA anticipated at the time that most PDURS output would be promotional labeling, and therefore “would only be required to be submitted at the time of initial dissemination, pursuant to these existing regulations.”

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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. , Forward-Looking Statements.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. This article takes a closer look at several key clusters in the region. Thanks to a prestigious academic legacy, Europe has long been a dominant region for life sciences.

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Policy Prescription

MAY 28, 2021

The title of one article in Kaiser Health News about PSM explains a lot: “Nonprofit Linked To PhRMA Rolls Out Campaign To Block Drug Imports.” and licensed by your state board of pharmacy.” state-licensed board of pharmacy licensed pharmacy.”. state-licensed board of pharmacy licensed pharmacy.”.

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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

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. The following PDUFA dates were obtained from publicly available sources.

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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. The following PDUFA dates were obtained from publicly available sources.

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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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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3, A: For FDA 1572 is a Statement of Investigator under US Regulations/Laws. IRBs are subject to 21 CFR 56 IRBs.

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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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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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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.

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Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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Drug Discovery World

JULY 13, 2023

In response to the incident, this article will examine the rules regarding the use of medicines that are unlicensed or off-label, and take a look at some high profile examples. Off-label use could be used to contribute to real-world evidence in favour of licensing a product for that use and repurposing the drug. What are the risks?

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The Pharma Data

JANUARY 12, 2021

As part of this role he built innovative, high-performing development teams and managed the Regeneron’s regulatory filings, interactions with regulatory agencies, product launches, and business development and licensing activities across its product portfolio. Dr. Graham earned an M.D., from the University of Adelaide in Australia.

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The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

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The Anticancer Fund

JUNE 23, 2023

Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context. Increasingly, we will be finding that implementation of positive data for repurposing is dependent on incentives, medical regulation and health economics.

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Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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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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Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. Ronapreve is being jointly developed by Roche and Regeneron.

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The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed Danyelza, which is exclusively licensed by MSK to Y-mAbs.

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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Agency IQ

MARCH 7, 2024

DAVID GREENBERG of Sanofi provided perspective based on an industry questionnaire , saying the transition will require industry to “re-activate or re-submit more than 300 TIV licenses, submit nearly 1500 variations, and update quality data in 174 countries.”

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The Pharma Data

MARCH 22, 2021

Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. LONDON and BOSTON, Jan. Gary S.

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Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. An “outsourcing facility” per Section 503B is a registered location that engages in the compounding of sterile drugs but is not required to be a licensed pharmacy.

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Agency IQ

MAY 10, 2024

That EO included some life sciences-specific standards and strategy development, including directing HHS to develop a new strategy on regulating the use of AI or AI-enabled tools in drug development and establish an HHS AI task force, which would focus on safety related to the various health-related uses of AI (e.g.,

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Codon

JANUARY 21, 2024

Sign up to receive articles from Asimov Press. We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. I can't patent it and license the fact that it is safe and feasible to do a challenge study with disease sample X to my competitors.

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The Pharma Data

JANUARY 15, 2021

and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. Related Articles: Darzalex Faspro (daratumumab and hyaluronidase-fihj) FDA Approval History. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc. link] Accessed January 2021. [8]

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Drug Discovery World

JULY 27, 2023

This is the second article in a two-part article where DDW’s Megan Thomas evaluates the current impact of Brexit on the UK drug discovery sector. In our recent article, we find that the UK has struggled to adopt either strategy, or to work out a competitive way forward. Read Part 1 here. An overview: Where does the UK stand?

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

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