Article, FDA Approval and Packaging - Drug Discovery Digest

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

Agency IQ

JULY 26, 2024

Prior to CARES Act reforms, FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as they adhered to pre-set terms under the monograph. On the other hand, data, information and comments to a proposed or final order should use the OTC Monographs@FDA portal.

FDA

FDA Production Regulations Packaging

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). After all, companies already have FDA-approved labels.

FDA

FDA FDA Approval Production Regulations

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

Advarra

JULY 19, 2022

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? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Could you please confirm?

Packaging

Packaging FDA Trials Regulations

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

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

Agency IQ

JULY 8, 2024

It also proposed several packaging changes to safeguard against misidentification. Six years later with the reauthorization of several FDA-industry user fee programs in 2012, Congress took the opportunity to set a series of policy changes into motion. However, the proposed rule sat in limbo for years without ever being finalized.

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

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

Disease

Disease FDA FDA Approval Treatment

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

The FDA CRL cited inspection findings that arose from a “multi-sponsor inspection of a third-party, contract manufacturing organization” which involved the monoclonal antibody drug substance for lebrikizumab. The clinical package, safety and label were not affected. However, BeiGene announced that it is seeking approval in the U.S.

Biosimilars

Biosimilars FDA Production Treatment

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

sensitivity and specificity) – including colonoscopy procedures and an FDA-approved stool-based test ( Cologuard ) – but comparatively low uptake, given the prevalence of CRC in the population. Notably, CRC screening methods are currently available and have generally high performance (i.e.,

FDA

FDA Laboratories Compliance Packaging

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

Agency IQ

NOVEMBER 10, 2023

. | 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. For a full review of MoCRA please see this AgencyIQ article.] MoCRA also provides labeling, reporting, and recordkeeping requirements. [

Production

Production FDA Compliance Regulations

New insights into the role of viral capsids in gene therapy safety

Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases.

Therapies

Therapies Virus DNA Compliance

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. Data on these novel approvals is published throughout the year by both CDER and CBER. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

FDA

FDA Biosimilars Science Drugs

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

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science

Science FDA Production Packaging

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

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Thanks for skimming. ❤️ Subscribe to support human writers. Nature Biotechnology. Gene Therapy.

DNA

DNA RNA Engineering Licensing

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

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. volume 4, Article number: 4782 (2014). 8 VENCLEXTA (venetoclax) [Package Insert].?North? Scientific Reports. 7 IMBRUVICA U.S.

Treatment

Treatment Therapies FDA FDA Approval

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. volume 4, Article number: 4782 (2014) 7 de Rooij MF, Kuil A, Geest CR, et al. 9 VENCLEXTA (venetoclax) [Package Insert].?

Treatment

Treatment FDA Therapies FDA Approval

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

Agency IQ

JUNE 16, 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. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations

Regulations FDA Science Production

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

Agency IQ

OCTOBER 27, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

FDA

FDA Science Regulations Production

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

Agency IQ

DECEMBER 1, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

FDA

FDA Science Regulations 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. Drug labeling : Labeling for the imported drug product must be consistent with the current required U.S.

FDA Approval

FDA Approval FDA Science Drugs

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

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

This article concludes Issue 05. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. million by 2004.

Clinical Trials

Clinical Trials Virus Vaccine DNA

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

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. C-8 Personal Injury Litigation , 87 F.4th 4th 315 (6th Cir.

Testimonials

Testimonials Drugs FDA Vaccine

No Liability for Not Manufacturing a Product

Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp.

Production

Production FDA Approval Packaging Doctors

Drug Discovery Digest

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

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

Webinars

Trending Sources

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

Webinars

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

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

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

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

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

New insights into the role of viral capsids in gene therapy safety

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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

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

Codon Digest: Injected Gene Editors

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

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

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

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

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

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

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

Making a “Miracle” HIV Medicine

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

No Liability for Not Manufacturing a Product

Stay Connected