2022, FDA Approval, Packaging and Regulations

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

Therapies FDA FDA Approval Treatment

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

Successful Applications of Real-World Data and Real-World Evidence in Rare Disease Programs

The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. The FDA also granted a second meeting for review. The agency encouraged further review of the data for potential reference as a historical control.

Disease

Disease FDA FDA Approval Regulations

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 After lengthy review, FDA approves Florida’s drug importation plan

Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Read our analysis of the lawsuit against the drug importation rule here. ]

FDA Approval

FDA Approval FDA Science Drugs

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757). AMG 451 / KHK4083.

Biosimilars

Biosimilars Production Treatment FDA

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

Article FDA Thank You FDA finalizes guidance on electronic submissions for OTC products

Agency IQ

JULY 26, 2024

BY AMANDA CONTI | JUL 24, 2024 9:57 PM CDT Background: Modernizing regulation of over-the-counter (OTC) products Nonprescription products, also called over-the-counter (OTC) products, must demonstrate the ability to be used safely and effectively without the supervision of a qualified healthcare professional.

FDA

FDA Production Packaging Regulations

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products. However, this is not an agency-initiated effort.

Science

Science FDA Packaging Production

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics.

Production

Production FDA 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. The December calendar is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

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

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). Each section would have other required sub-headings (e.g.,

FDA

FDA FDA Approval Production Regulations

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. November is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

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

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

DNA

DNA RNA Engineering Licensing

Beyond Steel Tanks

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. billion eggs in 2022 alone.

Engineering

Engineering Vaccine Production RNA

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

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Legally the State of California – or, more accurately, a private litigant purporting to exercise state powers – has no such power, because warnings on OTC drugs must be approved by the FDA.

Testimonials

Testimonials FDA Drugs Vaccine

Another Favorable Post-Albrecht MDL Preemption Decision

Drug & Device Law

SEPTEMBER 12, 2022

9, 2022), and the decision has a number of useful – for our side – rulings concerning branded drug preemption post- Merck Sharp & Dohme Corp. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. We recently received a copy of Pfaff v. Merck & Co. , Albrecht , 139 S.

FDA

FDA FDA Approval Regulations International

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). & Com.

Vaccine

Vaccine FDA FDA Approval Pharmacy

FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations

Drug & Device Law

MARCH 10, 2022

Kind LLC , 2022 WL 464149 (N.D. 2022), a decision holding that 21 U.S.C. § 3d —-, 2022 WL 390815 (N.D. The court acknowledged that “[o]n one level, the plaintiffs may have a point,” because consumers will in fact digest less protein than indicated on the product packaging. 2022 WL 390815, at *3. Kashi Co. , — F.

Regulations

Regulations FDA Packaging FDA Approval

Drug Discovery Digest

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

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

Trending Sources

Successful Applications of Real-World Data and Real-World Evidence in Rare Disease Programs

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

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Amgen Reports Second Quarter 2021 Financial Results

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

Article FDA Thank You FDA finalizes guidance on electronic submissions for OTC products

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

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

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 November 2023

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

Codon Digest: Injected Gene Editors

Beyond Steel Tanks

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

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Another Favorable Post-Albrecht MDL Preemption Decision

A Texas Mess

FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations

Stay Connected