The Pharma Data

APRIL 8, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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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

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

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. This is based on FDA’s reported 2018 review of the CLIA database. [2]

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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

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. The evolving upswing in NDSRI regulation is due to their link to cancer. Koblitz — We need to talk about nitrosamines.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

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Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 28, 2023 12:13 AM EDT Regulatory background The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., The FDA regulates prescription drug advertising under 21 CFR 202.1 , Prescription drug advertisements.

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The Pharma Data

JANUARY 24, 2021

On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. The FTD is designed to make important new drugs accessible to patients faster.

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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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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 2018; 9: 1595. 2018; 10 (1): 34–45. 2018; 3: 60-9.

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The Pharma Data

JULY 8, 2021

“By combining the expertise of the healthcare industry and the non-profit research community, we can carefully assess how biomedical data at this unprecedented scale is best utilized and hopefully accelerate the path from genetic discoveries towards novel therapeutics.”.

Disease 52

Disease Clinical Trials Government Research 52

FDA Law Blog: Biosimilars

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R.

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The Pharma Data

MAY 15, 2023

Before joining Lufthansa, he served as Group CFO at Barry Callebaut based in Switzerland from 2018 through 2020. Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Prior to that, he worked in multiple executive business and finance roles for Philips and KPMG.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

2018) , Arnold Partnership v. The PTO’s not-even-specious-argument, citing what certainly appears to us to be absolutely irrelevant case law, such as Novartis AG v. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed. Rogan , 246 F. 2d 460 (E.D. 2003) , and Biogen lnt’l v. Banner Life Sciences LLC, 956 F.3d 3d 1351 (Fed.

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. 2018; 9: 1595. 2018; 141 (1): 110-116. Minimal clinically important difference for asthma endpoints: an expert consensus report.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. The FDA action converts the 2018 accelerated approval to full approval. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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Production Clinical Trials International Small Molecule 52

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. Take for example FDA’s Unified Agenda announcement for ISO 13485 harmonization, which first occurred in the Spring of 2018 and was re-issued until a proposed rule was published in early 2022 (see our post here ).

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FDA Law Blog: Biosimilars

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

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Production FDA Treatment Disease 53

FDA Law Blog: Biosimilars

MARCH 14, 2023

AG Garland opined during his confirmation that he did not think it the best use of DOJ’s limited resources to prosecute those who are complying with the laws in those states that have legalized marijuana and are effectively regulating it. Deputy Attorney General James Cole advised U.S. 29, 2013), 3.

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. What does it mean for FDA staff?

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FDA Law Blog: Biosimilars

JANUARY 13, 2025

Failure to list coconut as an allergen has also been mentioned in several warning letters (see, e.g., here ) and as the reason for several product recalls, including a recent Class I recall in April 2024 (see also, e.g., Class II recalls in 2018 and 2022 for listing coconut as an ingredient but failing to disclose coconut in the allergen statement).

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FDA Law Blog: Biosimilars

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.

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International Production Regulations FDA 52

FDA Law Blog: Biosimilars

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. The Agency has reportedly been trying to improve the program, as we discussed in 2018 and 2020.

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FDA Laboratories Production International 52

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. By Adrienne R. However, reprocessing (cleaning and disinfection and/or sterilization) is typically performed by the end user in a healthcare facility rather than part of the manufacturing process.

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Animal Testing FDA Analytical Chemistry International 59

FDA Law Blog: Biosimilars

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. 2] Why is this an issue? However, two events conspired to undermine this prior guidance. the “ultimate user”).

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FDA Law Blog: Biosimilars

FEBRUARY 12, 2025

Around five years later, in November 2018, the Trump administration announced its own plans to ban menthol cigarettes, which faced significant opposition and was ultimately abandoned. 44,484 (July 24, 2013). As an aside, TPSAC and its 2011 report were not without controversy; although later overturned by the D.C.

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