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Regulatory Compliance

QbD Addresses API Supply in Orphan Drug Formulation

According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...

EDITORIAL: Combination Products and their Regulatory Pathway

Combination products are becoming increasingly important to pharmaceutical CDMOs like Alcami, said...

Blog: 505(b)(2): What You Need to Know

In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are...

Blog: Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to...

Blog: Regulatory Requirements for Early Phase Drug Product Development

Supporting a compound from discovery to clinical phases and potentially commercial phases requires...

White Paper: Insight into Orphan Drug Formulations and Regulations

The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that...

Beyond the Label: Four Challenges to Serialization

Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a...

Quota, Import, and Export Processes for DEA Controlled Substances

Controlled drug substances are scheduled based on medical use in treatment, potential for abuse,...

Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...

Listicle: Serialization CDMO Checklist

Given that serialization execution is new to many in the industry, what should drug developers look...

Serialization - Data Management Challenges

The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many...

Elemental Impurities USP: The Risk-Based Approach

The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods...

Elemental Impurities: Updated Regulatory Requirements

In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for...