2001 and Packaging - Drug Discovery Digest

Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. See also Article 11 of Directive 2001/83/EC.)

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Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

AUGUST 4, 2023

The document specifically notes that it applies to “medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC,” the current European pharmaceutical legislation. only” label can be affixed anywhere on the packaging. The FMD does not apply, but the “U.K.

Packaging

Packaging Licensing Licensing Regulations

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package.

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Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S. In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened. When such a situation is identified, it is noted in the product labeling.

Science

Science FDA Production Packaging

Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

JUNE 7, 2024

There are two codes that all 49 Notified Bodies received designation to – devices with a measuring function (MDS 1010) and devices that require packaging/labeling (MDT 2011).

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Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. active pharmaceutical ingredient, fill/finish, packaging/labeling). Read AgencyIQ’s analysis of the non-paper.] points of disruption).

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Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

In 2001, the FDA issued a guidance to “alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups.” It also proposed several packaging changes to safeguard against misidentification. However, the proposed rule sat in limbo for years without ever being finalized.

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Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Agency IQ

JUNE 21, 2024

It applies to products with marketing authorizations according to Regulation (EC) No 726/2004 and Directive 2001/83/EC, but does not apply to the transfer of the marketing authorization from one holder to another. Chapter 4 of Directive 2001/83/EC allows Member States to recognize assessments from another E.U.

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

APRIL 8, 2024

Once E2D(R1) has been finalized following comments received during public consultation, the note stated that “the final changes will be published via the E2B(R3) Implementation Guide package and ICH E2B(R3) Questions and Answers document.” This week, the FDA made significant progress towards the full implementation of E2B(R3) requirements.

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Article EMA Thank You European Commission reveals action plan to address medicines shortages

Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Changes that could be implemented rapidly include using different sources of raw materials and/or finished product, packaging, or changes to batch sizes, manufacturing sites, and equipment. healthcare systems for years.

Regulations

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Sebastian MacLean’s Naturally Massive

The Pharma Data

MAY 15, 2021

In fact, our “Average Joe” made such a dramatic transformation that, after filming of Facing Goliath was complete, he went on to be awarded the world wide Body For Life inpirational champion award of 2001. Your program takes nutrition, supplementation, and exercise and coordinates them as total package.

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Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Agency IQ

APRIL 12, 2024

Directive 2001/83/EC and Regulation (EC) No 726/2004. Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Generally, all MEPs supported the package in its current form, with political affiliations shaping the provisions each highlighted. citizens; 2.

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Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. These standards were vacated on 7/24/2001 and on 2/13/2002. This routine Methods Update Rule (rMUR) was proposed in February 2023.

Regulations

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Analysis Chemical Thank You What we expect the EPA to do in April 2024

Agency IQ

MARCH 29, 2024

April 2024 Restoration of Inadvertently-Removed Exemption from the Requirements of FIFRA (Proposed Rule Stage) 2070-AK25 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

Proposed Rule Stage Restoration of Inadvertently Removed Exemption From the Requirements of FIFRA 2070-AK25 August 2023 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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Levers for Biological Progress

Codon

NOVEMBER 1, 2024

More specifically, it reveals that the price to sequence a human genome fell from $100 million in 2001 to $700 by 2021; a stunning collapse in price. Perhaps you’ve seen this chart before, which shows the falling costs of DNA sequencing over the last two decades. The cost of sequencing a human genome.

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DNA RNA Molecular Biology Laboratories

The Foody Expansion of Nexus We’ve Been Waiting For

Drug & Device Law

JANUARY 31, 2024

Plaintiff’s fraud claims in Collyer allege that the packaging of four keto-friendly cereals was misleading because the cereals do not contain an ingredient pictured on the package. 341 (2001). Catalina Snacks Inc. LEXIS 9637 (N.D. But claims based on violations of the FDCA are preempted by Buckman Co.

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A Texas Mess

Drug & Device Law

JANUARY 4, 2024

341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). Plaintiffs Legal Committee , 531 U.S.

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How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. Smith rejected plaintiff’s analogy between books and drug package inserts. May 13, 2015) (contract involving multiple, identical “software package[s]” governed by UCC).

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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. 2001) (no causation where medical personnel “had no alternative other than to use the. . . Smith & Nephew Richards, Inc. , 2d 35, 41 (D.D.C.

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

2001) (no warning causation notwithstanding heeding presumption where prescriber testified that “the risk of him having a problem due to his [condition] was much greater than him taking the [drug]”) (applying Oklahoma law); Porterfield v. 2001), aff’d , 358 F.3d Stryker Co. , 3d 568, 576-77 (6th Cir. Parke, Davis & Co. ,

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FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations

Drug & Device Law

MARCH 10, 2022

341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. The court acknowledged that “[o]n one level, the plaintiffs may have a point,” because consumers will in fact digest less protein than indicated on the product packaging. A few weeks ago, we reported on Chong v.

Regulations

Regulations FDA Packaging FDA Approval

Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Implicitly relying on 21 U.S.C. §

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Drug Discovery Digest

Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

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Rapid delivery of toxicological material

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Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Article EMA Thank You European Commission reveals action plan to address medicines shortages

Sebastian MacLean’s Naturally Massive

Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Analysis Chemical Thank You What we expect the EPA to do in April 2024

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Levers for Biological Progress

The Foody Expansion of Nexus We’ve Been Waiting For

A Texas Mess

How the Fifty States View Electronic Data as a “Product”

Confident Learned Intermediaries Defeat Warning Causation

Unimpressed Learned Intermediaries Defeat Warning Causation

FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations

Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

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