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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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

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Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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Drug Hunter

AUGUST 21, 2023

The BBB is composed of specialized brain endothelial cells that regulate the distribution of molecules into and out of the brain from the blood. Unlike the endothelial BBB, the blood-cerebrospinal fluid-barrier (BCSFB) is made up of epithelial cells that similarly regulate the distribution of molecules between the blood and CSF.

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Drug Target Review

SEPTEMBER 26, 2023

5,6 The range of CNS-related toxicities encountered throughout drug development and post-market approval is vast, and includes abuse liability, suicidal ideation, emesis, sleep disorder and cognitive dysfunction to name a few. Ther Innov Regul Sci. 2010 Aug;31(4):331–50. Regul Toxicol Pharmacol RTP. 2018;53(4):519–25.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., See our memo summarizing CMS’s regulation here.

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Perficient: Drug Development

NOVEMBER 21, 2024

CFPB 1033 open banking requires financial firms to ease personal financial data access for consumers CFPB first proposed the rule in the Federal Register on October 31, 2023, accepted public comments on the regulation though December 29, 2023, then issued its final rule November 18, 2024.

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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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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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The Pharma Data

JANUARY 12, 2021

From 2010 to 2020, Dr Graham was VP of Strategic Program Direction, Immunology and Inflammation at Regeneron Pharmaceuticals, Inc., THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. Multiple IND’s, NDA/BLA filings and/or defense and multiple successful launches.

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FDA Law Blog: Biosimilars

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. In effect, these documents serve as road signs helping to direct new market entrants. Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process.

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The Pharma Data

JANUARY 18, 2021

The company’s common shares are listed on the Euronext Growth Paris market (Ticker: ALBPS -ISIN: FR0012816825). The company is based in Paris, France, and Cambridge, Massachusetts. Disclaimer This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts.

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Perficient: Drug Development

NOVEMBER 14, 2023

That’s where you as a healthcare marketer come in. My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. Let’s talk about five aspects of Gen Alpha that you need to keep in mind and start planning for in your healthcare marketing. The oldest of the Gen Alpha kids are only 13.

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Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). FDA said they would produce a guidance by the end of 2010, but did not.

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Drug Target Review

AUGUST 9, 2024

It continues from drug candidate screening and selection, prototype generation, preclinical validation, early clinical studies, to later clinical studies and post-market monitoring. Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success.

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Agency IQ

SEPTEMBER 29, 2023

The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. Proposal for a regulation Initiative entry E.U. CLP revision.

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Agency IQ

MARCH 25, 2024

Updates from IMDRF: What’s next for the working groups At the International Medical Device Regulators Forum (IMDRF) annual meeting in Washington, DC, regulators presented updates on the work underway within all seven IMDRF working groups. The group began with regulators from Australia, Brazil, Canada, China, the E.U.,

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Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness. Interestingly, Merck & Co.

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Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Under DSHEA, manufacturers are responsible for ensuring their products are safe prior to release to the market. An NDI is defined as a dietary ingredient not marketed before October 15, 1994.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. 2010) , however, the U.S.

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Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).

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Agency IQ

JANUARY 12, 2024

Exclusions are for substances that are managed by another agency or regulation, such as tobacco , drugs , munitions , food additives , cosmetics , pesticides , or nuclear materials. The most recent version of the document listing the categories is from 2010. EPA proposed updates to New Chemicals Regulations under TSCA in May 2023.

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Agency IQ

APRIL 26, 2024

BY RACHEL COE, MSC | APR 24, 2024 10:56 PM CDT Biosimilars and interchangeable products The FDA was first authorized to develop a pathway for the approval of biosimilar products in 2010 under the Biologics Price Competition and Innovation (BPCI) Act.

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Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. That ban on placing on the market extends to products using ingredients or combinations of ingredients that were subject to animal testing.

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The Pharma Data

MAY 14, 2021

You won’t believe the marketing techniques of some food companies, who have convinced the public that certain foods are healthy when in fact they are just the opposite.We’ll expose the truth behind these food products and how you can replace them with far healthier and just as, if not more, delicious options. .

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Codon

FEBRUARY 27, 2024

In 2010, seven members of a soccer team in Oregon were infected with norovirus after touching a reusable grocery bag, which was covered in viral particles, and then eating the food inside. A company called LuminOre will soon bring copper-coated air ducts to the market. million people in 2019. Credit: Qi S. Interfaces , 2023.

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The Pharma Data

JULY 8, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the UK.

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The Pharma Data

AUGUST 3, 2021

Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches. Acquired IPR&D expenses in 2021 were driven by the Five Prime Therapeutics acquisition. percentage points to 13.5%.

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The Pharma Data

OCTOBER 14, 2020

It was granted orphan drug designation for the treatment of narcolepsy in 2010. Food and Drug Administration in August 2019 for the treatment of excessive daytime sleepiness in adult patients with narcolepsy and has been commercially available in the U.S. since Q4 2019. WAKIX is a selective histamine 3 (H?)

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014.

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Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. market with Wegovy will, by 2030, require about one million liters of production capacity.

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The Pharma Data

APRIL 27, 2021

As the market leader in cardiovascular testing Roche is committed to innovation in cardiovascular care and these new intended uses are the first of many solutions planned over the next decade that could help improve the lives of millions of people.”. Cerebrovasc Dis (2010); 29(1):43-49. [15] ref:Marini, C. ref:Hannon, N.

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. It’s ostensibly marketed for diabetes, but we all know where the real money’s at. And it’s true, but only in an incomplete way. A complete, whole-brain connectome of the fruit fly has been published.

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. It’s ostensibly marketed for diabetes, but we all know where the real money’s at. And it’s true, but only in an incomplete way. A complete, whole-brain connectome of the fruit fly has been published.

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