Pharmaceuticals Documents

This document provides guidance for the assessment of abuse potential in drugs. It covers key decision points, recommended studies, and the process for NDA submission. This is crucial for ensuring drug safety and regulatory compliance.

This document provides detailed terms and conditions for the Nurtec ODT Savings Program. It includes eligibility criteria, instructions for pharmacists, and important disclaimers. Patients using the copay card should adhere to these guidelines to benefit from the program.

This file contains a list of manufacturers' abbreviations organized alphabetically, helping users to identify manufacturer names and their corresponding abbreviations.

This file provides industry guidance on investigating out-of-specification test results during pharmaceutical production. It includes detailed instructions and recommended practices for addressing OOS test cases. The document serves as a crucial resource for ensuring compliance with pharmaceutical quality standards.

This file contains the FDA's draft guidance on Budesonide including recommendations for studies to establish bioequivalence. It provides details about required in vitro and in vivo studies for different strengths of Budesonide. Important information about participant criteria for studies and the purpose of the guidance are also included.

This file contains the application for inspection of pharmaceutical manufacturing facilities. Users can request Good Manufacturing Practice (GMP) inspections. It is essential for compliance with national drug regulations in Uganda.

This document is a membership application form for the Pharmaceutical Society of South Africa. It provides essential information for pharmacists seeking membership. Fill it out accurately to ensure proper processing.

This document outlines the policies and procedures for the transfer of ownership of drug applications within the FDA. It serves as a guideline for applicants to ensure compliance with regulatory requirements during the ownership transition process. This manual aids in understanding responsibilities and the necessary steps for effective application management.

This file contains the agenda for the Maryland Board of Pharmacy's public board meeting on September 20, 2017. It includes reports from various committees and updates on operations, licensing, compliance, and more. The document is essential for stakeholders to keep track of board activities and decisions.

This document provides detailed instructions for applying for an Intern Pharmacist license in California. It covers processing time, required materials, and special cases for expedited review. Ensure all requirements are met to avoid application delays.

This form is used by pharmacies to request a contract with Humana. It includes sections for pharmacy details, types of services offered, and ownership information. Instructions for submission are also provided.

This document provides an order form for Revlimid® in Ireland. It includes essential details and instructions for healthcare professionals. Ensure to follow guidelines for proper completion and submission.