2003, Drugs, Marketing and Packaging

CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis

The Pharma Data

MARCH 26, 2021

The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. This CHMP opinion follows the recent label expansion by the US Food and Drug Administration to include LN. About lupus nephritis.

Therapies

Therapies Disease Treatment 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

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. The directives also had special scopes describing, for example, devices incorporating drugs, IVDs and medical devices in sterile condition, etc.

Regulations

Regulations Compliance Packaging Production

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

FDA

FDA FDA Approval Production Regulations

Analysis Chemical Thank You What we expect the EPA to do in December 2023

Agency IQ

DECEMBER 1, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C. 2020) (LEAN).

Regulations

Regulations Production Compliance Science

Analysis Chemical Thank You What we expect the EPA to do in November 2023

Agency IQ

OCTOBER 27, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

Regulations

Regulations Compliance Science Production

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

Agency IQ

MARCH 29, 2024

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act on May 20, 2003, and subsequently amended on July 13, 2006. section 7412(d)(6). The residual risk and technology review (RTR) was promulgated pursuant to CAA sections 112(f) and 112(d)(6) on July 13, 2020.

Regulations

Regulations Compliance Production Government

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. The Taconite Iron Ore Processing NESHAP was promulgated pursuant to section 112(d) of the CAA on October 30, 2003. section 7412(d)(6). section 7412(d)(6).

Regulations

Regulations Compliance Production Government

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

Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. For increased flexibility in bringing PIPs to market, a developer can also submit both. This action will address Louisiana Environmental Action Network v.

Regulations

Regulations Compliance Production Science

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

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

Production

Production International Trials Government

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . their patients.

Testimonials

Testimonials Doctors Production Laboratories

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. 2002); Tracker Marine, L.P. Ogle , 108 S.W.3d

Vaccine

Vaccine FDA FDA Approval Pharmacy

Drug Discovery Digest

CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis

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

Trending Sources

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

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Analysis Chemical Thank You What we expect the EPA to do in December 2023

Analysis Chemical Thank You What we expect the EPA to do in November 2023

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

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

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

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

Unimpressed Learned Intermediaries Defeat Warning Causation

A Texas Mess

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