Agency IQ

MAY 31, 2024

food packaging, kitchen and tableware and food processing equipment). Proposal for Regulation Initiative entry Revision of EU rules on food contact materials Adoption was planned for Q2 2023 This initiative will likely be postponed until the next Commission after June 2024. EU food safety policy includes rules on food contact materials (e.g.,

Regulations 40

Regulations Production International Government 40

Agency IQ

AUGUST 4, 2023

Articles 3(1) and 3(2) of the current European pharmaceutical regulation (EC) No 726/2004 set out requirements for medicinal products that must use the centralized procedure, rather than national approval pathways. These features should not be included on outer packaging or immediate packaging, if there is no outer packaging.

Packaging 40

Packaging Licensing Licensing Regulations 40

Agency IQ

MARCH 1, 2024

food packaging, kitchen and tableware and food processing equipment). Proposal for Regulation Initiative entry Revision of EU rules on food contact materials Adoption was planned for second quarter of 2023 This initiative will likely be postponed until the next Commission after June 2024.

Regulations 40

Regulations Production Packaging Science 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

Practical Cheminformatics

JANUARY 8, 2024

A 2004 paper by Vigers and Rizzi proposed a similar strategy for docking studies. In each example, the authors use a modified version of their open source package MolPAL to design molecules with a specified selectivity profile. The paper also provides links to several software packages for building MIL models.

Drugs 141

Drugs Small Molecule Bioinformatics Packaging 141

Agency IQ

FEBRUARY 2, 2024

food packaging, kitchen and tableware and food processing equipment). Proposal for Regulation Initiative entry Revision of EU rules on food contact materials This initiative will likely be postponed until the next Commission after June 2024. EU food safety policy includes rules on food contact materials (e.g.,

Regulations 40

Regulations Production Government Marketing 40

Agency IQ

JANUARY 4, 2024

The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments.

Regulations 40

Regulations Packaging Production Government 40

Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. And despite numerous high-profile, individual success stories in U.S. I cover this more extensively in The Good Virus.

Therapies 118

Therapies DNA Virus Clinical Trials 118

Agency IQ

DECEMBER 1, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. 2020) (LEAN).

Regulations 40

Regulations Production Compliance Science 40

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. Industry would benefit from aligned submission packages and less work to create the submissions.

Regulations 40

Regulations Production Marketing Vaccine 40

Agency IQ

OCTOBER 27, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. 2020) (LEAN). The residual risk and technology review (RTR) was promulgated pursuant to CAA 112(f) and 112(d)(6) on July 24, 2020.

Regulations 40

Regulations Compliance Science Production 40

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.

Pharmaceuticals 40

Pharmaceuticals Regulations Packaging Production 40

The Pharma Data

MAY 13, 2021

I have been training clients since 2004. 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. Certified 500 hour Yoga Instructor. Certified Pilates and Cycling Instructor.

Production 52

Production Treatment Vaccine Therapies 52

Agency IQ

DECEMBER 15, 2023

The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. 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. 2004) and related cases. EPA, 358 F.3d 3d 936 (D.C.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. 2020) (LEAN).

Regulations 40

Regulations Compliance Production Science 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. 2004) and related cases. The Lime Manufacturing NESHAP was promulgated pursuant to section 112(d) of the CAA on January 5, 2004. EPA, 358 F.3d 3d 936 (D.C.

Regulations 40

Regulations Compliance Government Science 40

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

JULY 13, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 ( see a Congressional Research Service report on its legislative history here ).

FDA 40

FDA Packaging Laboratories Testimonials 40

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. Restatement §402A, comments a, d-e. Graphic Process Co. ,

Production 52

Production International Trials Government 52

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. 2004) (another case we discussed in 2008 ), because the plaintiff failed to “produce[] evidence that the risk. . . Accord Wyeth Laboratories, Inc. Fortenberry , 530 So.2d 2d 688, 691 (Miss. Pfizer, Inc. ,

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JUNE 6, 2022

2004) (no causation where prescriber “continues to prescribe [similar] medication. . . 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. 2004 WL 5628157, at *5 (W.D.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

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. Warner-Lambert & Co. , 3d 85, 98 (2d Cir. 2006), aff’d by equally divided court , 552 U.S.

FDA Approval 64

FDA Approval FDA Regulations Production 64