FDA Approval and Workshop - Drug Discovery Digest

Article FDA: The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

JULY 21, 2023

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. However, the FDA Modernization Act of 1997 gave FDA the ability to exercise its scientific judgment in deciding exactly what it means to fulfill these requirements.

FDA

FDA FDA Approval DNA Production

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Broad Institute

JULY 26, 2022

Learn more Drug Repurposing Hub A curated and annotated collection of FDA-approved drugs, clinical trial drugs, and pre-clinical tool compounds. Learn more Technical Workshops Our primers and workshops help researchers learn about new technologies and advances in genetics, computation, and more.

Compound Screening

Compound Screening FDA Approval Engineering RNA

A new viral surveillance system in West Africa is showing the world how to prevent the next pandemic

Broad Institute

APRIL 25, 2024

Happi also led a workshop to train other researchers to analyze the genomic data and respond to Mpox outbreaks in their own communities. Sentinel is also developing a SHINE test to detect Lassa virus in rural clinics in Nigeria, where there are currently no FDA-approved diagnostics for the disease.

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Virus Hospitals Disease Government

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Bridging Innovation & Patient Care: The Growing Role of AI

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Artificial Intelligence (AI), Machine Learning (ML) and the FDA

The Premier Consulting Blog

NOVEMBER 12, 2023

Creating workshops and holding meetings to provide additional support to stakeholders on AI/ML in drug development. ( FDA, 2023 ) As the use of AI/ML in drug development expands, so will the regulatory requirements for these technologies.

FDA

FDA Drug Development Regulations FDA Approval

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

The FDA first proposed a rule on “Prescription Drug Labeling: Medication Guide Requirements” in 1995 , which was finalized in 1998. However, over the last decade the FDA and other stakeholders have acknowledged that there are opportunities for improvement. After all, companies already have FDA-approved labels.

FDA

FDA FDA Approval Production Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA

FDA Science Regulations Production

Article FDA Thank You In a first, FDA tackles treatments for stimulant use disorder

Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. Regulatory context FDA held a workshop in December 2019 to discuss development of substance use disorder therapies.

FDA

FDA Treatment Production Trials

Codon Digest: Agents Design Proteins

Codon

MAY 22, 2023

The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. Event The 2023 International Mammalian Synthetic Biology Workshop is on June 22-23 in San Jose. If you want to make an impact with biotechnology, materials are a great place to start.

DNA

DNA Engineering Science Trials

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

A study found that, of 23 FDA-approved biosimilar products, 21 had comparative efficacy established through one or more phase 3 clinical trials , which included “both an initial comparative efficacy period and additional follow-up, during which a subset of patients was switched between the biosimilar and reference products.”

Science

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IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

65 years or 18-64 years with cumulative illness rating scale score >6 or creatinine clearance <70 mL/min who had active disease requiring treatment per the International Workshop on CLL (iwCLL) criteria. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD.

Treatment

Treatment Therapies FDA FDA Approval

Codon Digest: Agents Design Proteins

Codon

MAY 22, 2023

The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. Event The 2023 International Mammalian Synthetic Biology Workshop is on June 22-23 in San Jose. If you want to make an impact with biotechnology, materials are a great place to start.

DNA

DNA Engineering Science Trials

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

JULY 21, 2023

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA.

FDA

FDA Clinical Trials Treatment Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended. The content will include both goals for enrollment of populations and rationales for those goals.

FDA

FDA Science Regulations Production

The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care

The Premier Consulting Blog

JANUARY 14, 2025

Offers fellowship programs and workshops, on-demand learning, and lecture series. Project Facilitate A single point of contact call and information Help oncology healthcare providers or regulatory professionals with submitting an Expanded Access Request through FDAs Expanded Access Program for an individual cancer patient.

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Article FDA: The next chapter in the ctDNA story: Still promising, not ready for prime time

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A new viral surveillance system in West Africa is showing the world how to prevent the next pandemic

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Artificial Intelligence (AI), Machine Learning (ML) and the FDA

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Article FDA Thank You In a first, FDA tackles treatments for stimulant use disorder

Codon Digest: Agents Design Proteins

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

Codon Digest: Agents Design Proteins

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care

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Article FDA: The next chapter in the ctDNA story: Still promising, not ready for prime time

Resources, services, and tools

Webinars

Trending Sources

A new viral surveillance system in West Africa is showing the world how to prevent the next pandemic

Webinars

Artificial Intelligence (AI), Machine Learning (ML) and the FDA

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Article FDA Thank You In a first, FDA tackles treatments for stimulant use disorder

Codon Digest: Agents Design Proteins

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

Codon Digest: Agents Design Proteins

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care

Stay Connected

The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care