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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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

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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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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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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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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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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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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. So, what is special about September 24, 2023? By Philip Won & Lisa M. Emphasis added.)

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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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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

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

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

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward.

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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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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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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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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Recent changes in drug approval processes, intellectual property laws, and pricing regulations have introduced both opportunities and challenges for dealmakers.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

The Part B program applies to calendar quarters beginning with the first quarter of 2023, and the Part D program applies to 12-month periods beginning on October 1, 2022. Accordingly, CMS issued first a preliminary guidance on each program, then, after a 30-day comment period, issued revised guidances on December 14, 2023.

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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

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

SEPTEMBER 3, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Some other noteworthy observations: More than half (8/15) of the recently posted decision summaries were from 2023. Gibbs — Thank you to readers of this blog. We are happy to report that fifteen new decision summaries have been posted as of August 28.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812(c)(c)(10).

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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

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 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. This is what OIRA is currently reviewing.

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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

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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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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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

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

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

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). By Jeffrey N.

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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

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. When we reviewed the De Novos that were granted between CY 2022 and 2024, we saw that only 28% had decision summaries posted: Posted 2022 2023 2024 Total Yes 18 of 23 (78%) 9 of 48 (19%) 1 of 30 (3%) 28 of 101 (28%) Dishearteningly, the trend is in the wrong direction.

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