2005 Licensing Packaging Pharmaceuticals 
The Premier Consulting Blog
NOVEMBER 16, 2022
Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs. What is an excipient?
Agency IQ
JANUARY 26, 2024
Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”
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Agency IQ
JUNE 16, 2023
Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects. On September 14, 2018, the U.S.
Drug & Device Law
JULY 31, 2023
The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Alaska 2005), predicted that Alaska would follow the Third Restatement “defin[ition] of a product as ‘tangible personal property distributed commercially for use or consumption.” Id. Munhoven v.
Drug & Device Law
MAY 30, 2022
The law presumes that licensed doctors know what they are doing. 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. . . . Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 692, 694 (5th Cir.
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