Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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The Premier Consulting Blog

NOVEMBER 20, 2023

The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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The Pharma Data

JUNE 2, 2023

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2028, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labour Code and authorized in the subscriber’s country.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., Final Guidance at 2.

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Agency IQ

JANUARY 26, 2024

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. Once the E.U.

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Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

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Agency IQ

MAY 17, 2024

The Creating Hope Reauthorization Act would extend the expiration date of the program for another four years , from September 30, 2024 to September 30, 2028. focuses on marketing exclusivity periods granted to orphan drugs. 7383, Retaining Access and Restoring Exclusivity (RARE) Act This proposed bill , sponsored by Reps.

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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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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The study is planned to begin in 2026 and conclude in 2028.

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The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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The Pharma Data

NOVEMBER 4, 2020

Amarin’s decision to continue to invest in expanding the market for VASCEPA also reflects its confidence in its manufacturing processes, which the company has built over a decade to achieve consistent, high-quality, stable supply to support anticipated global demand. Securities and Exchange Commission Regulation G.

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Agency IQ

OCTOBER 12, 2023

The Montreal Protocol is a major international environmental agreement that regulates the production and consumption of a group of about 100 ODS (hydrochlorofluorocarbons (HCFCs) and chlorofluorocarbons (CFCs)). The second rule focuses on regulations to better manage and reuse HFCs through a variety of technologies, including leak reduction.

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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 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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