FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

OCs recent 2023 Annual Report—covering the fiscal year from October ’22 to September ’23—puts some meat on the bones of those issues and describes how OC touches almost every area of enforcement that CDER undertakes. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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FDA Law Blog: Biosimilars

DECEMBER 7, 2023

We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing. On Day 2 of the conference, HPM’s Anne Walsh moderated a fascinating conversation about due diligence investigations relating to FDA-regulated industries.

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FDA Law Blog: Biosimilars

MARCH 12, 2023

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. When the public health emergency ends on May 11, 2023 , so do these exemptions. Hyman, Phelps & McNamara, P.C.’s

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. Hyman, Phelps & McNamara, P.C.’s s Faraz Siddiqui will speak on Tuesday, September 19, on Value-Based Agreements.

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Drug Channels

OCTOBER 23, 2023

Informa Connect’s Trade and Channel Strategies Hybrid Event | December 11-13, 2023 DoubleTree By Hilton | Philadelphia, PA Exclusive Offer–Be sure to use your exclusive promo code 23DC10 to save 10% off* of your registration. Copyright © 2006-2023 Pembroke Consulting, Inc. Why should you attend this pivotal event?

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. is the largest dedicated food and drug law firm in the country.

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FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.”

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FDA Law Blog: Biosimilars

JULY 21, 2023

Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series from October 10-26, a virtual three-week program designed to provide new lawyers and executives for the life sciences industry with a solid foundation for understanding the essentials as well as the intricacies of Hatch-Waxman and BPCIA litigation and regulation.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. He pointed out that Europe was the first region to approve biosimilars. She also does not believe that the problems with Europe’s medicines can be solved with regulation.

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FDA Law Blog: Biosimilars

MAY 10, 2023

DEA states the temporary rule will take effect today, and “extends the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency for six months – through November 11, 2023.” 30,038 (May 10, 2023). 802(54)(G) (which references CMS’s statutory definition of “practice of telemedicine”).

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FDA Law Blog: Biosimilars

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET.

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FDA Law Blog: Biosimilars

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023. The pandemic had changed the way people live, work and communicate.

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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 Law Blog: Biosimilars

MARCH 3, 2024

Mullen — FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards being finalized – and to a likely judicial showdown. The LDT rule has moved forward with astonishing speed, advancing from the release of the proposed rule on October 3, 2023 to OMB in less than five months. By Jeffrey N.

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FDA Law Blog: Biosimilars

JANUARY 8, 2024

Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. If this all holds true, it will follow the upward trend of the 2023 year in deals. Assessing risks in regulated industry requires the appropriate depth and breadth of regulatory expertise.

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Agency IQ

JULY 13, 2023

Keeping track of FDA’s user fee program performance It has been 9 months since the passage of legislation reauthorizing four of the user fee programs, the FDA User Fee Reauthorization Act of 2023. But during that time, how has the FDA been doing at meeting its obligations for PDUFA, MDUFA, GDUFA, BsUFA and OMUFA?

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

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Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. They are required for orphan drugs but not for biosimilars.

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FDA Law Blog: Biosimilars

JULY 31, 2023

Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). 78,282 (Dec. b)(5)(ii)).

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By now, more than a year ago, on October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims. CVM invited the public and stakeholders to comment on FDA’s regulation of animal foods with certain types of claims, that under the now withdrawn PPM, would be considered drug claims.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

16, 2023 ( DOJ Press Release ). 830(e)(1)(B)(i). “Regulated sellers” (retail distributors including pharmacies, grocery stores, general merchandise stores and mobile vendors) selling “scheduled listed chemical products” (“SCLPs”) (products containing ephedrine, PSE and phenylpropanolamine that may be marketed in the U.S. 21 U.S.C. §

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FDA Law Blog: Biosimilars

MAY 22, 2023

The California Department of Food and Agriculture (CDFA) issued regulations implementing Proposition 12 on September 1, 2022, but their implementation was enjoined until July 1, 2023, pending the Supreme Court’s decision. Our focus is on the decision’s practical impact, which could be felt almost immediately.

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FDA Law Blog: Biosimilars

JUNE 28, 2023

By Riëtte van Laack — On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, was introduced. On June 15, 2023, an amendment modeled after the Innovative FEED Act, was proposed as an amendment to S.1844

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea. Philip Won , of Hyman, Phelps & McNamara, P.C.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Terragene S.A.,

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FDA Law Blog: Biosimilars

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. The evolving upswing in NDSRI regulation is due to their link to cancer. Koblitz — We need to talk about nitrosamines.

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Agency IQ

SEPTEMBER 15, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 11, 2023 6:44 PM CDT Regulatory background: User fees and over-the-counter (OTC) drug reform Quick background: The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably.

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FDA Law Blog: Biosimilars

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. Timeline Section 524B became effective on March 29, 2023. Section 524B(b)(4) of the FD&C Act authorizes FDA to issue regulations with additional requirements for cyber devices.

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FDA Law Blog: Biosimilars

APRIL 18, 2023

Houck — In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances. By Larry K. Designation of 4-Piperidone as a List I Chemical, 88 Fed. 21,902, 21,907, 21,909 (to be codified at 21 C.F.R. a)(38) (Apr.

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FDA Law Blog: Biosimilars

MARCH 12, 2024

As we explained in September 2023 , then again in November 2023 , the FTC has intervened in the matter and asked 10 drug companies (really 8 given common ownerships of some of the relevant companies) to delist about 100 patents from the Orange Book that mainly cover the device constituent of a drug/device combination product.

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Vial

APRIL 10, 2024

The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2% This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations. IQVIA has a vast collection of healthcare information, including over 1.2

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FDA Law Blog: Biosimilars

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

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Agency IQ

SEPTEMBER 22, 2023

BY LAURA DIANGELO, MPH SEP 19, 2023 4:54 PM CDT Digital technologies as drug labeling: An intro to PDURS What is PDURS? The FDA regulates both product labeling ( 21 CFR 201 ) and promotional labeling ( 21 CFR 202 ). There are technically two kinds of prescription drug labeling, and PDURS could be either.

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