Agency IQ

MAY 3, 2024

12/29/2023 FDORA, Section 2512 Shortages : FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Clinical Trials 40

Drug Target Review

FEBRUARY 1, 2024

Two recent transactions both occurring in Q4 2023 prove this point. The organizing principle is the data package. We were able to license a molecule from a multi-national pharmaceutical company. Provided that existing clinical data are compelling, the disease areas we can consider are unlimited.

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Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. The following PDUFA dates were obtained from publicly available sources. and the E.C.

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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.

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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.

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Agency IQ

AUGUST 4, 2023

BY KIRSTEN MESSMER, PHD, RAC AUG 2, 2023 12:18 AM CDT Background The U.K.’s pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation.

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Packaging Licensing Licensing Regulations 40

Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. CDER approved 51 new molecular entities in FY 2023.

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FDA Biosimilars Science Production 52

Agency IQ

NOVEMBER 3, 2023

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? 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. What is the microbiome itself?

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Therapies Science FDA Production 40

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 latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Regulations FDA Science Production 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. The Fall 2022 edition was released in January 2023. June 2023 may be a busy month for the agency.

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Regulations Compliance Production Science 40

Agency IQ

JULY 22, 2024

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. 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). For a look at some other trends, see Agency’s Fiscal Year 2023 in Review ].

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Clinical Trials Trials Science FDA 52

Codon

FEBRUARY 13, 2024

Fast forward to 2023. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. At least a million people die from drug-resistant bacterial infections every year.

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Therapies Virus DNA Clinical Trials 121

Agency IQ

JANUARY 12, 2024

But while the plan may be approved, the decision by FDA still leaves open plenty of questions – and the potential that pharmaceutical trade groups may sue to halt the implementation of the plan. label for that product, including patient labeling such as Medication Guides and patient package inserts.

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Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.

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Regulations FDA Science Production 40

Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

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Drug & Device Law

JULY 31, 2023

Medicis Pharmaceutical Corp. , 2023 WL 2655586, at *3 (Cal. March 10, 2023) (quoting relevant §19(a) language); Flores v. Jacobs , 2023 WL 2655586, at *4. 2023 WL 2638314, at *4 (C.D. 20, 2022) (quoting Anthony ), reconsideration denied , 2023 WL 3321752 (C.D. March 9, 2023). April 14, 2023); Nazar v.

Production 52

Production International Trials Government 52

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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