Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions.

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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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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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The Pharma Data

DECEMBER 1, 2020

AXS-05 is also a sigma-1 receptor agonist; enhances brain levels of serotonin, noradrenaline, and dopamine, which are key neurotransmitters involved in the regulation of mood; and displays anti-inflammatory properties, which may be relevant to treating depression. 2007) Am J. AXS-05 is covered by more than 93 issued U.S.

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PLOS: DNA Science

SEPTEMBER 21, 2023

Two compelling talks will be “Long Noncoding RNAs as Key Regulators of Mood in Women,” from Orna Issler at the Neuroscience Institute at NYU Langone, and “Advising the US Congress and Policymakers on Issues Related to Pathogen Genomics, ” from Sarah Harvey, from the US Government Accountability Office.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. Similarly, the Court stated, “FDA’s silence regarding acetaminophen-specific warning does not preempt state law.”

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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. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. The FDA recently concluded its work on a proposed rule focused on PMI.

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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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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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Agency IQ

MARCH 7, 2024

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 It also means that most agencies covered by the bill will be required to absorb pay cost increases.”

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The Pharma Data

MAY 7, 2021

It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.”. . In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymization can be used,” wrote WHO and ICMRA.

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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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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. The investigational agent is considered IND exempt per the following criteria : The drug is lawfully marketed in the United States. The trial is in compliance with Federal regulations relating to the protection of human subjects.

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Codon

FEBRUARY 2, 2025

Opening windows is a simple and effective way to regulate indoor air quality by reducing particulate matter, the buildup of viruses and CO₂, and (aesthetically) bad smells. Since 2007, the UK has had a near-total ban on smoking in public indoor spaces and workplaces.

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Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are.

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Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision ).

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Drug & Device Law

AUGUST 24, 2023

Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention , a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. no[r] a marketing product” under Lanham Act). 2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). Leading Market Technologies, Inc. , Brown , 348 F.3d

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. Charting which justices joined which opinions on which issues looks like a psilocybin-induced Venn diagram.

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Drug & Device Law

MAY 19, 2023

In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone. Financial harm,” such as loss of a potential market “is a classic and paradigmatic form of injury in fact.” Sorsaia , 2023 WL 3211847, at *4.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

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Drug & Device Law

AUGUST 8, 2022

They contribute to the specific industry by way of sponsoring educational activities, and assisting in marketing, maintaining governmental relations, researching, establishing public relations, standardization and specification within the industry, gathering statistical data and responding to consumer needs and interests. 471 (11th Cir.

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Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. 124 (2007), which would also be knocked out by Dobbs if it sticks. the state action would be preempted. Strickland , 531 F.3d 3d 406 (6th Cir. Both of these cases applied the U.S. Carhart , 550 U.S.

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