Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. Medical Misinformation : FDA Commissioner ROBERT CALIFF has been heavily focused for much of the last two years on what he calls the negative health effects of medical misinformation.

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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.

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Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

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Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

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Agency IQ

JUNE 2, 2023

The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Another addition is an advanced notice of proposed rulemaking that seeks to “obtain information related to recalls of products subject to the jurisdiction of the FDA.”

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The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,

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Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES | FEB 21, 2024 7:48 PM CST Background: Dose-finding in oncology Traditionally, early development of oncology products has focused on identifying the maximum tolerated dose (MTD) of an investigational product. She then provided two real-world examples of a CUI in action.

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The Pharma Data

OCTOBER 1, 2021

The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.

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The Pharma Data

OCTOBER 15, 2020

Assembly Biosciences – Former Gilead Sciences CEO John McHutchison, currently president and CEO of Assembly, was named the recipient of the Advance 2020 Global Impact award. Prior to joining Genalyte, Hanna served as COO at Verily Life Sciences. Farrell Simon joins Trevi as head of U.S.

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The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.

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Agency IQ

JULY 28, 2023

This is referred to as “sole source” of a service, and might occur in situations where one company has a brand name product that does not have competition in the marketplace or could occur when a vendor retains significant advantage over competition (e.g., Industry wants its products reviewed quickly, efficiently and predictably.

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The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. In particular this study focuses on the role of the arginine-ornithine-polyamine axis, which is highly upregulated in GBM.

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Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

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The Pharma Data

FEBRUARY 8, 2021

In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”. Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In

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Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests requires for covered OTC products to be generally recognized as safe and effective (GRASE). The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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Agency IQ

FEBRUARY 12, 2024

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center (CBER, CDER, CDRH, CFSAN), as well as some additional FDA offices (like its Office of the Chief Scientist ). This list is known as the FDA’s “guidance agenda.”

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read or listen now.

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Agency IQ

MARCH 1, 2024

As it happens, EtO is essential for the sterilization of many medical devices, and the EtO final rule is expected to kick off a frantic period for regulators as they try to authorize substitute methods for device sterilization and ensure device products do not go into shortage. This is what OIRA is currently reviewing.

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The Pharma Data

NOVEMBER 9, 2020

Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada.

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Agency IQ

DECEMBER 1, 2023

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. This is already proving to be one of the FDA’s most-opposed actions in years.

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Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot. This is what OIRA is currently reviewing.

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Alta Sciences

JULY 25, 2024

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Tags Science and Health Weight 16 View the podcast.

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Agency IQ

JULY 12, 2024

The latest Spring 2024 Unified Agenda contains 53 regulations that FDA plans to publish related to human medical product regulation. The proposed amendment will clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures. and the E.C.

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