Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020.

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LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g.,

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The Pharma Data

JUNE 18, 2021

8 VENCLEXTA (venetoclax) [Package Insert].?North?Chicago, BTK signaling is needed by specific cancer cells to multiply and spread. 4,5 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. 2012;119(11):2590-2594. 7 IMBRUVICA U.S. Chicago, IL.:

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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The Pharma Data

JUNE 18, 2021

9 VENCLEXTA (venetoclax) [Package Insert].?North BTK signaling is needed by specific cancer cells to multiply and spread. 5,6 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. 2012;119(11):2590-2594. 8 IMBRUVICA U.S. Prescribing Information,?April

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Codon

NOVEMBER 1, 2024

This technique " opens large windows into the cell’s interior ," according to a 2013 review, allowing visualization of hidden structures that can’t be easily extracted or crystallized. It demands protocols, regulations, and collaborative efforts between human beings. In short, culture is an oft-overlooked bottleneck.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain. That would leave 19% of staff affected by furloughs.

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Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

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Drug & Device Law

AUGUST 3, 2023

472 (2013), had not arrived and plaintiffs had not stopped suing over alleged injuries from generic drugs. Plaintiffs did not even complain about the content of the package insert. The package insert is what most people think of as a prescription drug’s “label,” with its familiar format. Mensing , 564 U.S. Bartlett , 570 U.S.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Armstrong , 2013 WL 4853333, at *20-21 (E.D. 10, 2013) (free speech considerations precluded negligent misrepresentation suit over contents of a book); E.S.S. Palli , 2013 WL 1867072, at *4 (Conn. Brown , 348 F.3d

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Drug & Device Law

MAY 4, 2023

472 (2013), but that hinged largely on the duty of sameness—that is, the generic manufacturer cannot change the formulation of its drug to be different from the branded drug on which its ANDA approval depended. Ortho-McNeil-Janssen Pharms., 3d 281 (6th Cir. Bartlett , 570 U.S.

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Drug & Device Law

DECEMBER 19, 2022

2019), it simply misconstrued the FDA’s rather (that’s an understatement) complicated supplemental application/changes being effected regulation, 21 C.F.R. Sub-sub-sub-subsection (C) references the “highlights” part of the FDA’s general drug labeling regulation, 21 C.F.R. Albrecht , 139 S. Mensing , 564 U.S. a) of this chapter. . . .

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. 12 (citation and quotation marks omitted).

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Drug & Device Law

FEBRUARY 24, 2022

Because § 343-1(a) applies only to foods, the court’s detailed analysis of the relevant labeling regulations is not directly applicable to drug and device cases. 2013), aff’d, 784 F.3d Implicitly relying on 21 U.S.C. § 2022 WL 464149, at *1. 2022 WL 464149, at *4. Precisely so. 2d at 777; accord, e.g. , Blankenship v. 3d 979, 986 (E.D.

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