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

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure. are cybersecure.

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Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Sections 5 – 9 are labeled as Part A and cover clinical evaluation considerations.

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Perficient: Drug Development

NOVEMBER 14, 2023

Data privacy has become an increasingly complex subject, especially with the introduction of the California Consumer Privacy Act (CCPA) and similar regulations emerging in other states. Non-compliance with these regulations can result in hefty fines, as seen with Sephora’s recent $1.2

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The Pharma Data

JANUARY 24, 2021

The global esophageal cancer drugs market is estimated to grow by USD $1.5 Completion of the transaction is subject to customary closing conditions, including completion of due diligence, negotiation of definitive agreements and receipt of all necessary approvals. Persons”, as such term is defined in Regulations under the U.S.

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Perficient: Drug Development

FEBRUARY 22, 2024

Several books have been written on the concept, and many more refer to it when discussing differentiation and disruption within marketing and product development. It’s common that people view novel and innovative, first-to-market groups as having great ideas. The analogy of the “red ocean” of a saturated market drives home his point.

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Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Agency IQ

MAY 28, 2024

Updates to TSCA new chemicals regulations hit OIRA for review The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). TSCA itself has numerous subsections focused on different aspects of chemical regulation.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. provides a 10-year market exclusivity period. Orphan designation in the E.U.

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The Premier Consulting Blog

MAY 4, 2023

The global ophthalmic drugs market size was valued at $33.81 The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1].

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FDA Law Blog: Biosimilars

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2.

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Drug Channels

FEBRUARY 22, 2022

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.

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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.

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). 50,036 (Aug. at 50,037 codified at 21 C.F.R.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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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. That clause excludes those ingredients that were first marketed as drug ingredients. What led to NPA’s lawsuit?

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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FDA Law Blog: Biosimilars

MAY 15, 2023

By Riëtte van Laack — For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. AAFCO develops model regulations, that serve as model for the states.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims. Arizona’s House of Representatives passed a similar bill on February 22 of this year, which is now pending review by the State Senate.

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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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Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. I’ve been lucky to have seen several drugs make it all the way to market. Every drug has a story: an end game.

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The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e)

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The Premier Consulting Blog

MAY 11, 2023

In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. All regulated parties, including ophthalmic drug and device manufacturers, should take note. Unsurprisingly, the U.S. injectables).

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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. 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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Advarra

APRIL 19, 2023

Additionally, while the Food and Drug Administration (FDA) regulates all IVDs as medical devices, the agency has generally not enforced device regulations for certain IVDs designed, manufactured, and used within a single CLIA-certified laboratory. IVDs meeting this definition are known as laboratory developed tests (LDTs).

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. By Steven J. Gonzalez & Lisa M.

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FDA Law Blog: Biosimilars

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. These include: results of pre- and post-market clinical investigation(s) of the device (i.e., By Adrienne R.

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Agency IQ

APRIL 19, 2024

The British regulator is currently working on a proposal to restrict per- and polyfluoroalkyl substances in firefighting foams. s single market. regulators have begun to characterize as “GB regulations.” regulators have begun to characterize as “GB regulations.” s 25 Year Environment Plan.

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Agency IQ

OCTOBER 27, 2023

MHRA, FDA and Health Canada offer “guiding principles” for predetermined change control plans Regulators from the U.S., The regulators suggest that PCCPs need to be transparent, risk-based, bounded and operate throughout the product life cycle. Internationally, regulators are building a framework AI/ML in regulated products.

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Agency IQ

JANUARY 12, 2024

BY WALKER LIVINGSTON, ESQ | JAN 8, 2024 9:33 PM CST TSCA and PFAS The Environmental Protection Agency (EPA) implements the Toxic Substances Control Act (TSCA), which provides the basis for much of the chemical regulation in the United States. An AgencyIQ explainer on the EPA’s definition of PFAS may be reviewed here.]

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

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The Pharma Data

JANUARY 27, 2021

I look forward to updating the market when we have definitive clinical performance data.”. This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR). View source version on businesswire.com: [link].

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Agency IQ

SEPTEMBER 29, 2023

The intent is to create a single market for data, establish common European data spaces, and allow the companies that generate the data to keep control and maintain trade secrets. Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces.

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Agency IQ

NOVEMBER 3, 2023

In particular – potential issues with applying the policy to practice, the role of different stakeholders and the new proposed definitions. IVDs are regulated as medical devices in the U.S., not automated) tests conducted in single high-complexity CLIA labs by specialized personnel using legally marketed components.

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The Pharma Data

DECEMBER 12, 2020

Alexion ) have entered into a definitive agreement for AstraZeneca to acquire Alexion. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future. The acquisition will be immediately core earnings-accretive and value-enhancing, and is aligned with stated capital-allocation priorities.

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