The Premier Consulting Blog

MAY 4, 2023

The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. Therefore, the FDA will examine product classifications, especially for those products that have been regulated as drugs even though they may satisfy the device definition.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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Agency IQ

FEBRUARY 23, 2024

An AgencyIQ explainer on the EPA’s definition of PFAS may be reviewed here.] Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ].

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

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The Premier Consulting Blog

NOVEMBER 8, 2022

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) The drug product is packaged and shipped as a solid powder.

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The Pharma Data

JULY 11, 2021

In a previously-published Phase 2 study evaluating patients with UC, mirikizumab down-regulated several gene transcripts associated with inflamed mucosa and up-regulated gene transcripts correlated with healthy mucosa and markers of functional healing after 12 weeks, as defined by clinical disease indices of endoscopy and histology.

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The Premier Consulting Blog

MAY 11, 2023

In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. All regulated parties, including ophthalmic drug and device manufacturers, should take note. Unsurprisingly, the U.S. injectables).

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Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Used products and used product components are officially exempted from the regulations, as well as manufacturers that employ 25 or fewer people.

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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. Definitions from the existing E.U.

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Agency IQ

SEPTEMBER 15, 2023

California’s definition of ingredient is the same as defined at the federal level which is, any single chemical entity or mixture used as a component in the manufacture of a cosmetic product ( 21 CFR 700.3(e) A definition of the term “hold” is absent from both of these bills. Chapter 54.

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Agency IQ

MAY 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. If passed, the law would go into effect in January 2025.

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? Q: What is the definition of a drug? Yes, each drug has its own requirements.

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Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. An AgencyIQ explainer on the EPA’s definition of PFAS may be reviewed here.] since June 21, 2006.

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The Premier Consulting Blog

OCTOBER 11, 2022

During that meeting, the sponsor presented data by endpoint, which complemented the data package and indicated the benefits of treatment outweighed the risks. The agency encouraged further review of the data for potential reference as a historical control. The FDA also granted a second meeting for review.

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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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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Agency IQ

NOVEMBER 10, 2023

NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics. . | BY PATRICIA ISCARO, ESQ. | MoCRA also provides labeling, reporting, and recordkeeping requirements. [

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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Agency IQ

JUNE 26, 2023

Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). regulators.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation. Consensus does not require unanimity, but a general agreement. Existing published VCS may be identified internally by FDA or externally by stakeholders.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Pascal Soriot, CEO of AstraZeneca, pictured above.

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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. Postbiotic: “Preparation of inanimate micro-organisms and/or their components that confers a health benefit on the host,” according to the ISAPP definition.

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Agency IQ

JUNE 17, 2024

These are the lists of national and international standards the Commission plans to harmonize with its device and diagnostics regulations. But standards harmonized under the directives may not be used to show compliance with the new Medical Device Regulation, which replaced the MDD. This is similar to the situation in the U.S.,

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Agency IQ

JULY 22, 2024

While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

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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

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. The EPA updated and widened the definition of a PFAS in the final TSCA recordkeeping and reporting rule for PFAS published on October 11, 2023.

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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

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

JANUARY 19, 2024

The History of the ICH Q5A(R1) Guideline The International Council on Harmonization (ICH) Q5A(R1) Guideline, Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin , was first adopted by regulators in 1999. This bulk product contains both the final product (e.g., For the U.S.,

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Agency IQ

MAY 31, 2024

Guardant Vice President VICTORIA RAYMOND responded that the study was intended to demonstrate CRC sensitivity and specificity in the average risk screening population – as expected in an FDA package – and “was designed in that way, and so repeat testing was not part of the study design.” Adherence and access were a key point for the panel.

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Agency IQ

JULY 13, 2023

Consequently, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated “for the first time” after 1989 and flooring felt, rollboard, and corrugated, commercial, or specialty paper. However, the majority of this ban was overturned by Corrosion Proof Fittings v. EPA, 947 F.2d 2d 1201 (5th Cir.

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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. Industry wants its products reviewed quickly, efficiently and predictably.

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Agency IQ

AUGUST 23, 2024

By Laura DiAngelo, MPH | Aug 22, 2024 10:13 PM CDT Intro: Pre-Determined Change Control Plans in medical device regulation Post-market updates to authorized medical devices may, or may not, require a new submission to the FDA. In late 2022, the FDA gained new authority related to PCCPs. model drift).

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The Pharma Data

MAY 13, 2021

FACT: A recent study conducted by the Grocery Manufacturer’s Association states that OVER 80% of packaged foods eaten in the U.S. A better definition of a G.M.O. Did you know that DANGEROUS ingredients can be found in a majority of the food items you purchase from a grocery store or any of your favorite restaurants?

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The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. Reporting definitions. In making this assessment, the Board will also take into account any additional tax or other frictional costs compared to the announced demerger structure.

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The Pharma Data

JANUARY 9, 2021

See “Reconciliation of Non-GAAP Measures” for a definition of the terms and reconciliation tables.). 1) See “Reconciliation of Non-GAAP Measures” for a definition of terms and applicable reconciliation tables. . This growth primarily reflects the forecasted increase in total revenues discussed above.

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