2003 and Packaging - Drug Discovery Digest

Transitioning to eCTD v4.0

The Premier Consulting Blog

APRIL 27, 2023

In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 How can you prepare?

Packaging

Packaging FDA International Pharmaceuticals

The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage

The Premier Consulting Blog

DECEMBER 28, 2023

3] Understanding Medicare Coverage for IDE Studies The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allows for Medicare coverage of the routine costs of care provided to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. [4]

Regulations

Regulations FDA Packaging Clinical Trials

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

Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. That revised version remains in use today ( more on this below ).

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

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). 23 MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives Section 5.3.2

Regulations

Regulations Compliance Packaging Production

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

The Pharma Data

MARCH 26, 2021

Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy. [1]. About lupus nephritis.

Therapies

Therapies Disease Treatment Vaccine

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

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).

FDA

FDA FDA Approval Regulations Production

European Commission approves Benlysta for adult patients with active lupus nephritis

The Pharma Data

MAY 5, 2021

Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy. [1]. Premedication: An antihistamine, with/without an antipyretic, may be administered.

Therapies

Therapies Disease Treatment International

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

Agency IQ

OCTOBER 27, 2023

The current Primary Magnesium Refining NESHAP was promulgated pursuant to CAA section 112(d) on October 10, 2003. The Rubber Tire Manufacturing NESHAP, subpart XXXX, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on July 9, 2002, with corrections promulgated on March 12, 2003.

Regulations

Regulations Compliance Science Production

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

Agency IQ

FEBRUARY 2, 2024

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).

Regulations

Regulations Compliance Engineering Government

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

Agency IQ

JANUARY 4, 2024

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).

Regulations

Regulations Compliance Government Science

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

Agency IQ

DECEMBER 1, 2023

The current Primary Magnesium Refining NESHAP was promulgated pursuant to CAA section 112(d) on October 10, 2003. This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. 2020) (LEAN).

Regulations

Regulations Production Compliance 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. 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 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 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. The Coke Ovens: Pushing, Quenching, and Battery Stacks NESHAP, subpart CCCCC, was promulgated pursuant to section 112(d) of the CAA on April 14, 2003.

Regulations

Regulations Compliance Production Science

Muscle Imbalances RevealedMuscle Imbalances Revealed

The Pharma Data

MAY 13, 2021

I came across your package through Eric Cressey’s newsletter (I personally completed his Max Strength program and achieved great results) and immediately bought the webinars. 2003 ACE Personal Trainer of the Year. What I didn’t realize at the time was MIR was the tip of the iceberg. Stephen Holt. BabyBoomerFitnessAuthority.com.

Production

Production Treatment Vaccine Research

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. 2003) (risk differences between two types of vaccines held insufficient to justify a warning that one was “preferred”); Thomas , 949 F.2d Accord Wyeth Laboratories, Inc. Fortenberry , 530 So.2d

Testimonials

Testimonials Doctors Production Laboratories

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

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. The Complaint nowhere alleges that either the persons allegedly targeted or the persons purportedly targeting their “wild conspiracy theories” have any connection to Texas, which leaves us wondering how the Texas Deceptive Trade Practices Act (“DTPA”) could possibly apply. See Henry Schein, Inc. Stromboe , 102 S.W.3d

Vaccine

Vaccine FDA FDA Approval Pharmacy

Drug Discovery Digest

Transitioning to eCTD v4.0

The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage

Trending Sources

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

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

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

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

European Commission approves Benlysta for adult patients with active lupus nephritis

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 February

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

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

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

Muscle Imbalances RevealedMuscle Imbalances Revealed

Unimpressed Learned Intermediaries Defeat Warning Causation

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

A Texas Mess

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