Vial

FEBRUARY 23, 2024

The HITECH Act invested $19 billion into health information technology, such as EMRs and digital patient portals, to serve as an economic stimulus package and incentivize their adoption by healthcare providers.

Clinical Trials 52

Clinical Trials Clinical Research Trials Hospitals 52

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.

FDA 40

FDA Production Regulations Vaccine 40

Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. When Louis Miller, now Chief of Malaria Cell Biology at the NIH, attended a malaria conference in Shanghai in 2008, he asked: Who discovered artemisinin? Nobody had an answer.

Drugs 129

Drugs Science Research Doctors 129

Agency IQ

SEPTEMBER 15, 2023

of the California Safe Drinking Water and Toxic Enforcement Act of 1986, the European Union’s (EU) Regulation on the Registration, Evaluation, Authorization of Chemicals ( REACH, 1907/2006 ), and the EU’s Classification, Labeling, and Packaging Regulation ( CLP 1272/2008 ), among others.

Regulations 40

Regulations Packaging Production Government 40

Agency IQ

AUGUST 30, 2024

The good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance.

Compliance 40

Compliance Regulations Packaging Production 40

Agency IQ

JUNE 21, 2024

Regulation (EC) No 1234/2008 (Variations Regulation) provides the procedures for implementing the different types of variations. Industry would benefit from aligned submission packages and less work to create the submissions. Some guidance on reliance procedures with regulators outside the E.U.

Regulations 40

Regulations Production Marketing Vaccine 40

Agency IQ

JULY 26, 2024

Chemical CAS RN (or EC No.) they are now subject to the provisions qualifying them for PIC notification) and the final substance is being moved from part 2 to part 3 of the annex, because terbufos was included in May 2023 in annex III of the Rotterdam Convention).

Regulations 40

Regulations International Packaging Compliance 40

Agency IQ

MAY 3, 2024

Planned legislation Description Type of act Link European Chemicals Agency (ECHA) – updated fees and charges Adoption planned for Q1 2024 Initiative amends Commission Regulation 340/2008 on the fees and charges payable to ECHA. food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Packaging Production International 40

Agency IQ

SEPTEMBER 22, 2023

Member states are aso required by the Classification Labelling and Packaging (CLP) Regulation (1272/2008/EC) to establish poison centers capable of “ receiving information on the composition of hazardous mixtures (detergents, paints, adhesives etc.)” [ The respective poison centers for all member states are listed here.]

Regulations 40

Regulations Production Packaging Marketing 40

Agency IQ

AUGUST 30, 2024

CAD and CMRD) are coming to a close this month (CLP is the acronym for Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures; CAD and CMRD stand for chemical agents directive and carcinogens, mutagens, reprotoxic substances directive, respectively).

Regulations 40

Regulations Production Government Packaging 40

Agency IQ

SEPTEMBER 29, 2023

On October 5, the European Parliament (EP) plenary is scheduled to debate and likely vote on its position on the proposed regulation for reforming Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Packaging Production International 40

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 40

Regulations Compliance Packaging Production 40

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 40

FDA FDA Approval Production Regulations 40

Agency IQ

JUNE 7, 2024

Analysis and next steps The new rules represent a noteworthy change in the way these pesticide components will be regulated after Regulation (EU) 2024/1487 enters into force on June 19, 2024.

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

AUGUST 2, 2024

Planned legislation Description Type of act Link European Chemicals Agency (ECHA) – updated fees and charges Adoption planned for Q1 2024 Initiative amends Commission Regulation 340/2008 on the fees and charges payable to ECHA. food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Production Packaging International 40

The Pharma Data

MAY 15, 2021

This is an unbelievably exciting package… designed you so don’t risk a single cent putting it to the test in your own home. I’m damn proud of Warrior Zero and this outstanding package I’ve been able to put together for you on this page. If it doesn’t however…. That means, if you’re reading this message, the deal is still on.

Production 52

Production Packaging Doctors Science 52

Agency IQ

MAY 31, 2024

Planned legislation Description Type of act Link European Chemicals Agency (ECHA) – updated fees and charges Adoption planned for Q1 2024 Initiative amends Commission Regulation 340/2008 on the fees and charges payable to ECHA. food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Production International Government 40

Agency IQ

NOVEMBER 27, 2023

A 2008 survey from FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) – the successor to its Office of Prescription Drug Promotion (OPDP) – found that 10 of 30 randomly selected television advertisements would have violated FDA’s proposed standards.

FDA 40

FDA Science Drugs Regulations 40

Agency IQ

AUGUST 23, 2024

This includes final guidance from 2008 on “ The PMA Supplement Decision-Making Process ” and two 2017 guidance documents informing modifications to devices under a 510(k) pre-market notification ( one general modifications guidance and another on software updates ).

Science 40

Science FDA Marketing Production 40

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. Circuit granted EPA a voluntary remand in 2008 for the Agency to re-evaluate the MACT floors established in 1995 based on the D.C. EPA, 358 F.3d 3d 936 (D.C.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

DECEMBER 1, 2023

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on December 14, 1994, and January 10, 2008, respectively. In 2009, the EPA granted reconsideration on a petition to reconsider the 2008 rule and subsequently issues an administrative stay of the 2008 rule.

Regulations 40

Regulations Production Compliance Science 40

Agency IQ

OCTOBER 27, 2023

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on December 14, 1994, and January 10, 2008, respectively. EPA recently reclassified several areas as Severe nonattainment areas for the 2008 ozone NAAQS.

Regulations 40

Regulations Compliance Science Production 40

Agency IQ

MARCH 29, 2024

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act(CAA) on December 14, 1994, and January 10, 2008, respectively. Similarly, the Group I and II Polymers and Resins NESHAP were most recently updated when the agency conducted its RTR on December 16, 2008, and April 21, 2011.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

Section 2008 Improved Consumer Confidence Reports amended the Safe Drinking Water Act section 1414(c)(4) to revise requirements for Consumer Confidence Reports (CCR). EPA recently reclassified several areas as Severe nonattainment areas for the 2008 ozone NAAQS. These areas include Dallas-Fort Worth, TX, Denver-Boulder-Greeley-Ft.

Regulations 40

Regulations Compliance Production Science 40

The Premier Consulting Blog

APRIL 27, 2023

the current default version internationally, was established in 2008. 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 and around the world, and eCTD v3.2.2,

Packaging 52

Packaging FDA International Pharmaceuticals 52

Agency IQ

NOVEMBER 20, 2023

The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA). In effect, Dal Pan asserted that the contracting period would need to be delayed in order to better inform what, exactly, the agency is looking to contract for – and the technical packages they’d need.

Science 40

Science FDA Research Regulations 40

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

Regulations 40

Regulations Compliance Engineering Government 40

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. Circuit granted EPA a voluntary remand in 2008 for the Agency to re-evaluate the MACT floors established in 1995 based on the D.C. EPA, 358 F.3d 3d 936 (D.C.

Regulations 40

Regulations Compliance Government Science 40

Drug & Device Law

MARCH 11, 2024

Section 136v(b) mandates that states may “not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter” (emphasis added). 312, 326 (2008) (rejecting dissent’s reliance on Silkwood ; precluding “judicial recourse. . . Kerr-McGee Corp. , See Riegel v.

Regulations 52

Regulations Government Production Packaging 52

Drug & Device Law

JULY 31, 2023

2008 WL 11344752, at *2 (D. April 22, 2008); Isham v. 2008 WL 2622791, at *4 (N.D. July, 1, 2008) (“provision of a manual for software does not convert the transaction from one for a software service to one for both tangible goods and service”). 2008) (all quoting and following Pierson definition of product).

Production 52

Production International Trials Government 52

Drug & Device Law

MAY 4, 2023

Relatedly, the claim for “false marketing”—the court’s term, whereas the OPLA calls it “Product conforming to representation made by manufacturer” and it would usually be called “misrepresentation”—was really a re-packaged warnings claim. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v.

FDA Approval 64

FDA Approval FDA Regulations Production 64

Drug & Device Law

MARCH 23, 2023

Southern Source Packaging, LLC , 568 F. As one of the cited decisions put it, “Courts distinguish ‘true supplementation’ (e.g., correcting inadvertent errors or omissions) from gamesmanship, and have therefore repeatedly rejected attempts to avert summary judgment by ‘supplementing’ an expert report with a ‘new and improved’ expert report.”

Testimonials 59

Testimonials Packaging Compliance Trials 59

Drug & Device Law

DECEMBER 19, 2022

one HDPE resin to another HDPE resin) of a packaging component that may affect the impurity profile of the drug product. (vi) Changes in a drug product container closure system that controls the drug product delivered to a patient or changes in the type (e.g., Even further confirmation is found in the FDA’s regulatory history for §314.70(b),

FDA 59

FDA Regulations Production Drugs 59

Drug & Device Law

JUNE 6, 2022

2008) (applying Texas law and discussed here ), several times. 2008); In re Pradaxa Cases , 2019 WL 6043514, at *5-6 (Cal. 2000) (no causation where prescribing physician “testified that, had the packaging contained an extra warning as to [the plaintiff’s condition], he still would have prescribed it for the plaintiff”), aff’d , 21 F.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. Our 2008 post discussed Ackermann v. 2008) (applying Texas law), where the prescribing psychologist did not discuss risk of suicide with clinically depressed patients that did not seem to be suicidal. 3d 203 (5th Cir.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

MAY 16, 2022

W]hen consumers read “known to the State of California to cause cancer” on the packaging of a food or beverage product, they would believe “that such products pose a risk of cancer in humans. . . . 2008) (see our post here ), that broadly authorize private litigants to enforce state statutory requirements. 3d 1170, 1181-83 (Cal.

Government 59

Government Production Packaging FDA 59

Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”

FDA 69

FDA Production Trials Government 69