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

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. We have drafted a memorandum that summarizes the main provisions of this proposed rule and notes where the regulation differs from the guidances.

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FDA Law Blog: Biosimilars

OCTOBER 27, 2024

The plaintiffs are suing FDA over its December 2022 final guidance, “ Homeopathic Drug Products ,” which we discussed here. Before enactment of the CARES Act, FDA issued regulations to add, remove, or make changes to OTC monographs based on whether they were generally recognized as safe and effective (“GRASE”).

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. The Court found them all unpersuasive.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. FDA explicitly said as much in the 1991 preamble accompanying proposed patent restoration regulations.

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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

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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FDA Law Blog: Biosimilars

SEPTEMBER 3, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Not counting the two recent De Novo decisions that were not part of the original analysis, the total number of decision summaries posted for De Novos granted between CY 2022 and 2024 YTD is now 45/101 (43%). Gibbs — Thank you to readers of this blog.

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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. While 510(k)s are reviewed through the Office of Health Technology level, 513(g)s also include review from the Office of Regulatory Programs and sometimes even the Regulation, Policy, and Guidance staff.

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FDA Law Blog: Biosimilars

MAY 16, 2024

But there has been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA regulations allowed employees to divert staggering quantities of controlled substances.

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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

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ). Patent Nos. Patent Nos.

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FDA Law Blog: Biosimilars

SEPTEMBER 29, 2023

Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers.

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. addresses the Inflation Reduction Act of 2022.

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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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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

JULY 22, 2024

s John W.M. s John W.M.

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Vial

APRIL 10, 2024

increase at constant currency compared to the corresponding period in 2022. By mid-2022, Vial had secured over $100 million in venture funding, with General Catalyst leading a $67 million Series B financing round in November 2022. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2%

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

During a routine inspection in June 2022, Drug Enforcement Administration (“DEA”) diversion investigators determined that People’s Rx pharmacy violated recordkeeping requirements, improperly dispensed controlled substances to practitioners for office stock and issued prescriptions without authorization. 16, 2023 ( DOJ Press Release ).

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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.

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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. In 2022 and 2021, the Spring Unified Agenda was released in early/mid June.

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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

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

JUNE 28, 2023

In September 1998, CVM published Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods With Drug Claims , which provides guidance on how CVM regulates substances for animals. On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims.

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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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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. Read AgencyIQ analysis here.

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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 18, 2024

Briefly, on October 11, 2022, FDA issued a letter in response to a new dietary ingredient notification (NDIN) by Inner Mongolia Kingdomway Pharmaceutical Ltd. In a supplemental letter dated November 4, 2022, FDA addressed MKP’s arguments that FDA’s determination was incorrect. What led to NPA’s lawsuit?

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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FDA Law Blog: Biosimilars

MAY 9, 2023

In the interview, Khan spoke about the Commission’s efforts to regulate geolocation data trackers so that they don’t abuse their abilities. Khan was referencing a suit that FTC and DOJ filed against Kochava, a prominent location data broker, in August 2022. The interview aired on Monday, May 1.

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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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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 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

APRIL 16, 2024

We wrote a memorandum summarizing CMS’ regulation here. In April 2022, Vanda Pharmaceuticals filed a complaint in the Maryland Federal District Court to challenge CMS’ definition on Administrative Procedure Act (APA) grounds. We previously blogged on the district court’s decision last year.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. 1067, which first reared its head in Spring 2022 as an amendment to S.4348,

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FDA Law Blog: Biosimilars

APRIL 3, 2023

Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations. See our memo summarizing CMS’s regulation here. In 2014 Vanda introduced Hetlioz (tasimelteon) capsules to treat a rare sleep disorder.

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