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.

FDA 52

FDA Packaging Production Compliance 52

Agency IQ

JANUARY 26, 2024

In response to this report, FDA researchers published extensive data on the SLEP program, reviewing the findings for 122 drugs products (3005 different lots) evaluated by the program between 1986 and 2005. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date.

Science 40

Science FDA Packaging Production 40

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.

Regulations 40

Regulations Compliance Production Science 40

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.

Production 52

Production International Trials Government 52

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. . . . 2005) (no causation where prescriber “testified that he selected. . . Accord Wyeth Laboratories, Inc.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JANUARY 4, 2024

The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005: To encourage the expeditious development and deployment of medical countermeasures during a public health emergency. . . [by] 247d-6d(b)(8). “To Alabama State Board of Pharmacy , 61 F.4th 4th 902, 905 (11th Cir.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59