Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

FDA 40

FDA Packaging Science Drugs 40

Agency IQ

APRIL 12, 2024

Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Heated debates on the most contentious issues resulted in a compromise text for each legislation in March The proposal package , consisting of one directive and one regulation, was finally released in April 2023. citizens; 2.

Pharmaceuticals 40

Pharmaceuticals Regulations Packaging Marketing 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. The EPA received a petition for reconsideration of the 2006 rulemaking and, in 2007, EPA announced its reconsideration of several aspects of the rule.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

MARCH 29, 2024

These subparts were originally promulgated pursuant to section 111(b) of the CAA on June 29,1990 (subparts III and NNN), August 31, 1993 (subpart RRR), and November 16, 2007 (subpart VVa). On April 25, 2023, the EPA published a proposed rulemaking in the Federal Register (see 88 FR 25080) for this action.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

The Primary Copper Smelting area source NESHAP, subpart EEEEEE, was promulgated pursuant to section 112(d) of the CAA on January 23, 2007. This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration.

Regulations 40

Regulations Compliance Production Science 40

Codon

FEBRUARY 2, 2025

In 1965, Congress mandated labeling on all cigarette packaging that warned consumers about the risks of smoking. Since 2007, the UK has had a near-total ban on smoking in public indoor spaces and workplaces. This reduction was largely driven by legislation and campaigns to educate people about the risks of smoking.

Disease 76

Disease Vaccine Nurses Engineering 76

Codon

FEBRUARY 9, 2025

To achieve this, E11 Bio synthesizes protein barcodes (short peptides with unique amino acid sequences), packages them into AAV vectors (engineered, non-harmful viruses for drug delivery), and delivers these into the brain tissue. A light microscope and image of a barcoded hippocampus at E11 Bio.

Research 100

Research Disease Engineering Regulations 100

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 EPA received a petition for reconsideration of the 2006 rulemaking and, in 2007, EPA announced its reconsideration of several aspects of the rule.

Regulations 40

Regulations Government Compliance Science 40

Codon

FEBRUARY 23, 2025

Starting in 2007, a human trial in Ecuador and Peru found that this drug duo reduced HIV incidence by 44 percent among men who have sex with men; adherence issues likely prevented full protection. 8 This would be 1,000 times cheaper than the current price and still give Gilead a 30 percent profit margin.

Clinical Trials 68

Clinical Trials Virus Vaccine DNA 68

Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. The bottom line, however, is that the package of benefits that the MAO offers is up to the MAO. Philip Morris Cos. ,

Production 52

Production Regulations FDA Compliance Compliance 52

Drug & Device Law

JULY 31, 2023

2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). 2007), held that “defective computer software may give rise to strict products liability in tort.” Buhimschi , 2007 WL 2902896, at *16 (E.D. 28, 2007), aff’d , 396 F. Henry , 2007 WL 2743097, at *2 (W.D.

Production 52

Production Trials International Government 52

Drug & Device Law

SEPTEMBER 15, 2022

7, 2014) (applying New York law) (“courts have refused to graft onto the adequacy standard a requirement that a package insert must include specific adverse event frequencies.”); Hurley v. Our first post, on what we then called “comparative toxicity” warnings, is here , from 2007. Eli Lilly & Co. , 3d 391, 405 (S.D.N.Y.

Production 52

Production Packaging International Research 52

Drug & Device Law

JUNE 6, 2022

2007 WL 2526402, at *3 (D. 5, 2007) (no causation where prescriber “testified that despite [the decedent’s] death and updated warnings from Defendant, he continues to prescribe [the drug] for his patients because he believes [it] is a safe and effective medicine”) (applying California law); Latiolais v. 2007 WL 5861354, at *4 (C.D.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

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. 2007) (no causation where prescriber “questioned the relative risks of the adverse effects” versus the plaintiff’s condition and “continued to prescribe the. . . Accord Wyeth Laboratories, Inc. 477 F.Supp.2d

Testimonials 59

Testimonials Doctors Production Laboratories 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.” Hence, the statute applied.

FDA 69

FDA Production Trials Government 69