The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. Implementation Package v1.5

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Packaging FDA International Pharmaceuticals 52

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 Taconite Iron Ore Processing NESHAP was promulgated pursuant to section 112(d) of the CAA on October 30, 2003. section 7412(d)(6). section 7412(d)(6).

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Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. The Coke Ovens: Pushing, Quenching, and Battery Stacks NESHAP, subpart CCCCC, was promulgated pursuant to section 112(d) of the CAA on April 14, 2003.

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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. The Taconite Iron Ore Processing NESHAP was promulgated pursuant to section 112(d) of the CAA on October 30, 2003. section 7412(d)(6).

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Regulations Compliance Government Science 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). Medicis Pharmaceutical Corp. ,

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Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. Janssen Pharmaceuticals, Inc. Wyeth Pharmaceuticals, Inc. 692, 694 (5th Cir. 3d 1223 (11th Cir. 3d 203 (5th Cir.

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Testimonials Doctors Production Laboratories 59