2005 Licensing Packaging Regulations 
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.
Agency IQ
JANUARY 26, 2024
Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Agency IQ
JUNE 16, 2023
Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.
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.” 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. City of Madera , 2005 WL 1683736, at *13 (E.D. July 11, 2005), aff’d , 277 F.
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. Plaintiffs Legal Committee , 531 U.S.
Expert insights. Personalized for you.
52 
Let's personalize your content