Topical Ophthalmic Drug Products Quality Considerations – Guidance for Industry

Topical Ophthalmic Drug Products Quality Considerations – Guidance for Industry

In the intricate realm of pharmaceuticals, where precision and safety are paramount, the FDA’s “Quality Considerations for Topical Ophthalmic Drug Products Guidance for Industry” serves as a beacon. Topical ophthalmic drugs play a pivotal role in managing ocular conditions, ranging from infections to glaucoma. Ensuring the quality of these products is not just a regulatory…

As a Technical Document Writer, is there still value in using the Australian Government Style Manual in the age of AI?  
|

As a Technical Document Writer, is there still value in using the Australian Government Style Manual in the age of AI?  

Available either in print or online, the Australian Government Style Manual was created by the Australia Public Service Commission and is a reference that directs technical document writers in the appropriate use of language, such as use of spelling (especially those American Z’s), grammar, punctuation and writing conventions. It is also equally useful for scientific…

Technology Transfer: The Bridge Between Academia and Industry
| |

Technology Transfer: The Bridge Between Academia and Industry

The definition of technology transfer (TT) may vary depending on the type of TT. It is generally referred as bridge between academia and industry, though it may also involve transfer of knowledge within the industry. In the pharmaceutical industry, TT would very often include transfer of new product and process from development to manufacturing. It…

FDA Issues Final Rule Aligning Quality System Management Regulation (QMSR) with ISO 13485:2016

FDA Issues Final Rule Aligning Quality System Management Regulation (QMSR) with ISO 13485:2016

On January 31, 2024, the U.S. Food and Drug Administration (FDA) introduced a significant regulatory update through the issuance of the final rule for the Quality Management System Regulation (QMSR). This rule is aims to align the existing United States’ Quality System (QS) Regulation, as outlined in 21 CFR 820, with the internationally recognized ISO…

Therapeutic Vaping Products (Nicotine) – Changed Regulations in Australia

Therapeutic Vaping Products (Nicotine) – Changed Regulations in Australia

Public health concerns regarding vaping products Every year, more than 8 million people die from smoking-related illnesses, including 1.3 million non-smokers exposed to second-hand smoke. (Source: WHO 2023.) With the evolution of vaping products, including pharmaceutical nicotine vapes, cannabis vapes, and non-therapeutic vapes, people are curious to know if nicotine addictions and smoking-related health harms…