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.

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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. For the regulation , this centered on market exclusivity for orphan drugs and whether there should be a separate category for medicinal products addressing unmet need.

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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.

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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).

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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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 ).

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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. ,

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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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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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