The Premier Consulting Blog

NOVEMBER 16, 2022

One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Therefore, when excipients are selected for formulating a new drug product, it is essential that they either meet current FDA standards or are qualified for use in the drug product.

FDA 52

FDA Packaging Production Compliance 52

Codon

APRIL 9, 2024

(sweet wormwood), from which artemisinin, the antimalarial drug, was first isolated. However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. ’s Good Manufacturing Practice standards for drug production. 1 At the same time, the U.S.

Drugs 129

Drugs Science Research Doctors 129

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

Science 40

Science FDA Packaging Production 40

The Pharma Data

NOVEMBER 2, 2020

Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. Based on the results from the HORIZON study Oncopeptides has submitted a New Drug Application (NDA) to the U.S. CET on 3 November 2020. About Oncopeptides.

Marketing 40

Marketing Regulations Packaging Pharmaceutical Companies 40

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. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR. On September 14, 2018, the U.S.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. EPA is considering options to partially restore the exemption, particularly regarding pediculicide products. 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