Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates.

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FDA Law Blog: Biosimilars

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.”

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FDA Law Blog: Biosimilars

APRIL 25, 2023

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

The definition goes on to list potential options for such tests: cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods such as bioprinting, as well as animal tests. For more on FDORA’s other provisions, see HPM’s complete summary here ). FDORA § 3209(a)(2).

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FDA Law Blog: Biosimilars

JUNE 13, 2024

Though the Court acknowledged that the definition of the term “drug” is broad enough to include the ProAir HFA inhaler, the Court found that “this broad statutory definition of drug does not suffice to establish the Inhaler Patents claim the drug for which Teva submitted its application.”

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FDA Law Blog: Biosimilars

MAY 6, 2024

FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions.

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FDA Law Blog: Biosimilars

JULY 23, 2024

Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

While a DEA registration is not required to sell these products, by definition, any person selling these products is a “regulated person” and all sales of these products are considered “regulated transactions.” 21 U.S.C. § 21 U.S.C. §§ 802(38), (39)(B).

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. What is noteworthy about this proposed definition is that it adds a new requirement that “[a] manufacturer must make data available to CMS to support its finding.”

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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. The 2023 Economic Report on U.S.

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Agency IQ

OCTOBER 6, 2023

While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA further retained some definitions in the QSMR. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3, Revised § 820.3

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed.

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Drug Channels

SEPTEMBER 12, 2023

2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors Economic Report on Pharmaceutical Wholesalers and Specialty Distributors is the definitive, nonpartisan resource thoroughly updates our annual exploration of the distribution industry’s interactions with—and services for—other participants in our healthcare system.

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Pharmaceuticals Pharmacy Biosimilars Licensing 40

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. On August 28 of this year, NPA sued FDA challenging FDA’s determination that NMN is excluded from the dietary supplement definition.

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FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

From Chapter 1 (My First Generic Drug Client), through Chapter 4 (The Hatch-Waxman Act), to Chapter 12 (My Prescription for the Future), the 208-page “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer” is definitely worth a read!

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Drugs Pharmaceuticals 59

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. 1396r-8(k)(3). date of payment, date of shipment, date of invoice, etc.).

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Drugs Regulations International Production 59

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. § 802(a) (7)(A)).

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The Pharma Data

MARCH 30, 2021

–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Alydia Health announced today that they have entered into a definitive agreement pursuant to which, after the intended Merck spinoff of Organon, Organon will acquire Alydia Health. . & MENLO PARK, Calif.–(BUSINESS

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FDA Law Blog: Biosimilars

OCTOBER 9, 2023

As applied to manufacturer assistance, CMS did not adopt a single interpretation of the statutory or regulatory definition of “cost sharing.” The Court specifically concluded that the rule “rests on two contradictory interpretations of the statute” and “conflict[s] with the regulatory definition.”

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Pharmacy Regulations Drugs 40

FDA Law Blog: Biosimilars

AUGUST 14, 2024

Among other topics, the memorandum summarizes CMS’s proposed regulations for both these Part B and Part D inflation rebate programs, including: Key definitions; The drugs to which the rebates apply; Methods of calculating and applying rebates; Processes for reporting, reconciling, and paying rebates; and Penalties and enforcement.

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Regulations Drugs Pharmaceuticals 59

FDA Law Blog: Biosimilars

MAY 15, 2023

A major component of AAFCO is its work on ingredient definitions, specifying what ingredients may be use in animal feed under what conditions. AAFCO’s ingredient definitions are not federal regulations and do not have the force or effect of federal law. The goal is to create uniformity to facilitate interstate commerce.

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Agency IQ

JUNE 9, 2023

Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. Generic and biosimilar developers benefit from earlier market entry.

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FDA Law Blog: Biosimilars

JUNE 12, 2023

Moreover, ingredients used in pet food must be approved by FDA, affirmed or listed as Generally Recognized as Safe (GRAS) by FDA, or go through the AAFCO definition process. PFI’s president has stated that “[t]he biggest issue is the inconsistency in state interpretation of AAFCO label definitions.

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Agency IQ

SEPTEMBER 22, 2023

As captured in the definition of the PDURS itself, the software must be “disseminated by or on behalf of a drug sponsor.” This definition is carried forward in the new PDURS framework: “A software function [per the Cures Act] is any distinct purpose of the software—in this case, prescription drug use-related software.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

If enacted, the legislation would amend the FMIA and PPIA to establish definitions for “imitation” and “cell-cultured” meat and poultry products, and revise the definitions of “meat” and “poultry” to exclude such products. This particular federal legislative effort, however, continues the debate.

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Protein Production Production DNA Regulations 59

FDA Law Blog: Biosimilars

MARCH 5, 2024

Even if the company did obtain approval, such approval would likely be after generic competition for Farxiga enters the market, in which case the definition of a qualifying single source drug would no longer apply to Farxiga. AstraZeneca argued it would very likely have products in future lists of drugs selected for negotiations.

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FDA Law Blog: Biosimilars

JUNE 28, 2023

The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

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Regulations Production Drugs Disease 45

FDA Law Blog: Biosimilars

JANUARY 18, 2024

within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. Marijuana” outside of the CSA definition, including hemp, mature stalks, fiber from the mature stalks, oil or cake made from seeds, and sterilized seeds incapable of germination are not controlled and not subject to the recommendation.

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FDA FDA Approval Treatment Drugs 69

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

Change to the IVD definition First, the mechanics of the change. The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R.

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Laboratories FDA Regulations Production 64

FDA Law Blog: Biosimilars

FEBRUARY 6, 2024

In fairness, we’d note that FDA reports that inspections are on the rise—but definitely not back to pre-pandemic levels. The Subcommittee majority has held prior hearings and written letters about these problems, as the issue has vexed FDA in recent years.

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FDA Law Blog: Biosimilars

MARCH 16, 2023

Thus, ironically the definition of “simple” is anything but and is almost certain to lead to debates about what, exactly, is simple. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.

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Marketing Regulations Laboratories FDA 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. Non-applicable drugs (e.g.,

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Compliance Drugs Pharmacy Licensing 105

FDA Law Blog: Biosimilars

JUNE 17, 2024

Medical gas manufacturers and 503B outsourcing facilities—both of which meet the definition of “manufacturer”—are excluded from the Quality Report. drugs subject to an open drug efficacy study implementation ( DESI ) program proceeding).

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Pharmaceuticals FDA Production Drugs 59

FDA Law Blog: Biosimilars

JULY 8, 2024

The Court acknowledged that the determination as to whether it concerns a public or private right has not been “definitively explained” but stressed that the public right is an exception and should be interpreted narrowly. The dissent agreed that the critical question is whether the matter concerns a private or public right.

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Government Trials FDA Clinical Trials 59

FDA Law Blog: Biosimilars

MARCH 7, 2024

FDA uses that definition to designate small businesses eligible for a reduced user fee. Sections 738(d)(2)(A) and (e)(2)(A) of the FD&C Act define a “small business” as an entity that reported $100 million or less of gross receipts or sales in its most recent income tax return.

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