Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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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. We’re about to find out.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Drug Channels

MARCH 5, 2024

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s latest live video webinar: Drug Channel Implications of the Inflation Reduction Act This event will be broadcast live on Friday, April 5, 2024, from 12:00 p.m. This event is part of The Drug Channels 2024 Video Webinar Series.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Conversations in Drug Development Trends

JULY 9, 2024

Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies.

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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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FDA Law Blog: Biosimilars

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C. HPM is a co-sponsor of the event. The event is hosted by by Porzio, Bromberg & Newman.

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FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

Early research suggests that OTC hearing aids can be as effective as prescription hearing aids in certain circumstances, and published literature that FDA has reviewed has left the agency seeming hopeful. But the GAO Report highlights the lack of research on OTC hearing aids thus far.

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The Pharma Data

JULY 28, 2021

Combining its strength in generic medicines and knowledge of specialty drugs, Teva is developing its pipeline and portfolio to increase access to affordable medicines, including through the development of biosimilars—highly similar less-costly versions of the reference branded biologic drugs, which are made from living cells or organisms.

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). from 2024 to reach US$129.8 ’s services include supporting life sciences research, analytical solutions, and diagnostics or developing and manufacturing therapeutic interventions. billion by 2029.

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Agency IQ

DECEMBER 1, 2023

This effort will most likely be set up in early Q1 of 2024. This December look-ahead includes all activities that we anticipate will occur through January 1, 2024. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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FDA Law Blog: Biosimilars

JUNE 10, 2024

Director Larry Houck will participate as a panelist focusing on this timely topic in the Food and Drug Law Institute’s (“FDLI’s”) “High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling” webinar June 12, 2024, 2:00-3:30 pm ET. Information and registration is available at the conference webpage here.

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FDA Law Blog: Biosimilars

AUGUST 18, 2024

When we reviewed the De Novos that were granted between CY 2022 and 2024, we saw that only 28% had decision summaries posted: Posted 2022 2023 2024 Total Yes 18 of 23 (78%) 9 of 48 (19%) 1 of 30 (3%) 28 of 101 (28%) Dishearteningly, the trend is in the wrong direction. The same cannot be said for De Novos from January or February.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

Prior to joining HPM as a Director, Deb spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research.

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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.  Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15 trillion by 2028.

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Agency IQ

MARCH 1, 2024

In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. Notably, this explanation of what “excepted staff” does is different in both version of the 2024 contingency plan than what appeared in the 2023 contingency plan. What is happening now?

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Agency IQ

SEPTEMBER 15, 2023

While fees payable for OTC Monograph Order Request (OMOR) submissions have previously been published in March, six months after the start of the fiscal year, the fees are now being published prior to the start of the 2024 fiscal year. This likely means that industry will have to wait until March 2024 for facility fee information.

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FDA Law Blog: Biosimilars

NOVEMBER 20, 2023

Claud — The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). Cavazzoni told staff that the changes at OPQ will strengthen “connections between assessment, inspection, surveillance, research, policy, and administrative operations.”

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FDA Law Blog: Biosimilars

JUNE 10, 2024

As a reminder, the BIMO program oversees a wide range of activities related to FDA-regulated research, including human and animal studies, and covers the full gamut of FDA centers (CDER, CBER, CDRH, CFSAN, CTP, and CVM). Maintain accurate and detailed records of all research activities, including raw data, test results, and correspondence.

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The Pharma Data

MAY 18, 2021

As part of this network modernization plan, Sandoz will phase out the current production of oral APIs at the Les Franqueses site in Spain, which it plans to close in 2024. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Agency IQ

OCTOBER 27, 2023

policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024. Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

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FDA Law Blog: Biosimilars

MARCH 3, 2024

3558 ) on January 25, 2024. Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. 22-3675, 2024 U.S. 2024) at 13 (“Decision”). Under this law, manufacturers may not deny contract pharmacies access to a covered entity’s 340B drugs, or deny 340B drug pricing to covered entities who use contract pharmacies for distribution. Code Ann. §

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The Pharma Data

JUNE 24, 2021

The anticipated primary completion date is late-2024. Professor of Oncology at the University of Utah School of Medicine, Senior Director for Clinical Research Innovation at Huntsman Cancer Institute and member of the TALAPRO-3 steering committee. Source link:[link].

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below. We have tried to sort guidance documents by topic area.

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The Pharma Data

MAY 15, 2023

Huebscher , non-executive board member in companies, institutions and former CEO of Solvias Group, a Swiss contract research firm, which she led between 2014 and 2021. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. The new board members are: Dr. Karen J.

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FDA Law Blog: Biosimilars

DECEMBER 6, 2023

Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers. The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R.

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Agency IQ

JUNE 29, 2023

Because drug advertisements take many forms, the OPDP has long conducted research on drug advertisements and promotions to discern which factors may play a role. What about that OPDP research on quantitative claims, anyways? Its study aimed to study consumers’ “interpretation of specific quantitative claims.”

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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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.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., OIG claims a review will be complete in 2024. not discontinued) and are available for sale.

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