FDA Approval, Laboratories, Packaging and Regulations

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification.

FDA

FDA Regulations Production Packaging

Q&A: The IND Journey Phase I – Navigating Success

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. A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting?

Packaging

Packaging FDA Regulations Trials

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

Therapies

Therapies Science FDA Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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.

Regulations

Regulations FDA Science Production

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Tears in the stomach or intestines and changes in certain laboratory tests can happen. RINVOQ ® (upadacitinib) [Package Insert]. ClinicalTrials.gov. AbbVie Inc. .

Treatment

Treatment Disease FDA Vaccine

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

KRAS testing of patients with metastatic non-small cell lung cancer (NSCLC) now stands at approximately 70%, driven by increased next generation sequencing (NGS) utilization and KRAS G12C educational efforts, and 46 of the 50 top testing laboratories are now identifying the KRAS G12C mutation as actionable in their lab reports. Bemarituzumab.

Biosimilars

Biosimilars Production Treatment FDA

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Click to Tweet : #BREAKING: The #FDA has approved another treatment option for people living with #HIV. Hepatotoxicity: Hepatic adverse events were reported.

FDA Approval

FDA Approval Treatment RNA FDA

Article FDA Thank You AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain

Agency IQ

MAY 31, 2024

Shield is already available as a laboratory developed test (LDT), which allowed the sponsor to utilize a unique data set: Adherence The PMA for the Shield blood test was submitted to FDA in May 2023. Analysis & What’s Next Up front, the advisory committee panel meeting touched on several hot topics in diagnostics regulation.

FDA

FDA Laboratories Compliance Packaging

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

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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. This is already proving to be one of the FDA’s most-opposed actions in years.

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

What We Expect the FDA to do in November 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.

FDA

FDA Science Regulations Production

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

DNA

DNA RNA Engineering Licensing

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

FDA

FDA Packaging Science Drugs

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. These gene-edited bananas were submitted for regulatory approval in the Philippines (a top five global exporter of bananas) sometime last year. on bioRxiv.

Vaccine

Vaccine DNA Virus Engineering

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. These gene-edited bananas were submitted for regulatory approval in the Philippines (a top five global exporter of bananas) sometime last year. on bioRxiv.

Vaccine

Vaccine DNA Virus Engineering

Drug Discovery Digest

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Q&A: The IND Journey Phase I – Navigating Success

Trending Sources

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

Amgen Reports Second Quarter 2021 Financial Results

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Article FDA Thank You AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain

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

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

Codon Digest: Injected Gene Editors

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon Digest: Ghana Approves A Better Malaria Vaccine

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