2001, Marketing and Packaging - Drug Discovery Digest

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. For the regulation , this centered on market exclusivity for orphan drugs and whether there should be a separate category for medicinal products addressing unmet need.

Pharmaceuticals

Pharmaceuticals Regulations Packaging Marketing

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

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

Packaging

Packaging Licensing Licensing Regulations

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

The regulations increase focus on post-market requirements and expect continuous and instantaneous updates to all reports and documents when either the product or the benefit-risk ratio changes. Key Documents and Dates Single Market Compliance Space (NANDO) database Notified Body applications for designation

Regulations

Regulations Compliance Packaging Production

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. Next, the European Commission collected data from marketing authorization holders, suppliers and national competent authorities for the selected medicines. Read AgencyIQ’s analysis of the non-paper.]

Regulations

Regulations Production Packaging FDA

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

Agency IQ

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S.

Science

Science FDA Production Packaging

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. The provision aims to ensure patient access to medicines where they have been marketed. healthcare systems for years. Several legislative efforts are under way to ensure supply of medicines in the E.U.

Regulations

Regulations Pharmaceuticals International Production

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.

FDA

FDA Regulations Production Packaging

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

Agency IQ

JUNE 21, 2024

For products that seek approval through the “centralized marketing authorization application,” the EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a scientific evaluation and issues a positive or negative opinion on whether an authorization should be granted. Conversely, authorization in specific E.U.

Regulations

Regulations Marketing Production Vaccine

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

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA

FDA Production Regulations Vaccine

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. In the pursuit of truth, science needs no market; technology, on the other hand, has no reality beyond its application and exists only in relation to the marketplace.

DNA

DNA RNA Molecular Biology Laboratories

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

Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

Regulations

Regulations Compliance Production Science

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. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.

Regulations

Regulations Compliance Production Government

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

Agency IQ

MARCH 29, 2024

April 2024 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) 2040-AG02 EPA supports market-based mechanisms, including water quality trading under the Clean Water Act (CWA). EPA plans to continue its outreach efforts with affected parties.

Regulations

Regulations Compliance Production Government

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. 247d-6d(b)(8). Strike two. The suit “relates to” – at least – “the. . . development, clinical testing or investigation, . . Strike three.

Vaccine

Vaccine FDA FDA Approval Production

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

Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). Leading Market Technologies, Inc. , 2016) (applying Georgia law), held that digital marketing software was “a service and not a product.” Gray Loon Outdoor Marketing.

Production

Production Trials International Government

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.

Testimonials

Testimonials Production Drugs Pharmaceuticals

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. ,

Testimonials

Testimonials Doctors Production Laboratories

Drug Discovery Digest

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

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

Trending Sources

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

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

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

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

Levers for Biological Progress

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

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

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

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