Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. Labcorp, IQVIA, ICON, and WuXi Clinical (based on 2022 annual revenue). of total revenue).

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Clinical Trials Clinical Research Trials Laboratories 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

As a Principal Drug Regulatory Expert, Dr. Beitz joins HP&M’s Drug Development Team, which is comprised of attorneys and regulatory experts who assist companies on a range of drug and biological product legal, regulatory, and policy issues.

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FDA Drugs Drug Development Production 48

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Clinical Trials 40

Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

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FDA Science Regulations Production 40

Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 7:50 PM EDT | UPDATED JUN 26, 2023 12:41 PM EDT Note: This calendar also include some activities scheduled to take the last week of June, after this piece is published. Was supposed to be finalized as of June 24, 2022. not discontinued) and are available for sale.

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FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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FDA Science Biosimilars Clinical Trials 40

The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. Nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route.

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FDA Animal Testing Pharmacokinetics Small Molecule 52

FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 , Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”).

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FDA Regulations Production Drugs 59

FDA Law Blog: Biosimilars

MARCH 13, 2024

On April 29, 2022, FDA approved Tap Pharmaceuticals, AG’s (“Tap’s”) NDA 215809 for EMERZA (levothyroxine sodium) Oral Solution. That segues us nicely into a bonus piece. Part 3½: Seriously? A PTE application (Docket No. FDA-2023-E-2391 ) was subsequently submitted to the PTO seeking an extension of U.S.

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FDA FDA Approval Production Marketing 57

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

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FDA Science Biosimilars Regulations 40