Agency IQ

OCTOBER 27, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches.

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Regulations Compliance Science Production 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.

Pharmaceuticals 40

Pharmaceuticals Packaging Regulations Production 40

Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

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Regulations FDA Science Production 40

Agency IQ

OCTOBER 20, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Regulations Production Packaging Treatment 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.

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Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C. EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). This action will address Louisiana Environmental Action Network v.

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Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps.

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FDA Science Biosimilars Regulations 40

Codon

JUNE 2, 2024

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.

Laboratories 140

Laboratories Research Disease Science 140

Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006) (video game “clearly qualifies as an ‘artistic work’ entitled to First Amendment protection”). 2006), aff’d , 279 F. Leading Market Technologies, Inc. , Paragon 28, Inc.

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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.

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Testimonials Doctors Production Laboratories 59

Drug & Device Law

JUNE 6, 2022

at 172 (“continued to prescribe” the drug “a lot” and “believed it to be an effective drug for many of her patients”). where the prescriber: testified that he would still be willing to prescribe [the drug] to his patients even if there was evidence showing that it could cause [plaintiff’s condition] in rare cases. 3d 75 (Fla.

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Drug & Device Law

MAY 4, 2023

In the show position might be that the temporal relationship between a new medical condition and the use of a drug or medical device does not, without more, prove causation. 2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. Ortho-McNeil-Janssen Pharms.,

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