Pharma Blog
Essential Skills for Pharma Auditors in Today’s Regulatory Landscape
As the pharmaceutical industry continues to evolve amidst regulatory changes and technological advancements, the role of auditors has never been more crucial. Pharma auditors are the guardians of compliance, quality, and integrity, ensuring that products meet the highest standards of safety and efficacy. The importance of their work cannot be ... Read More
Differences in Filing for Drug Master File in US, Canada and Europe
In Europe, when filing for a Drug Master File (DMF), the process revolves around stringent regulatory requirements set by the European Medicines Agency (EMA). In the United States, filing for a Drug Master File (DMF) is governed by the Food and Drug Administration (FDA), which has its unique set of ... Read More
LYRICA (Pregabalin) | Drug Digest
LYRICA (pregabalin) has been Pfizer’s flagship blockbuster brand for many years due to the fact that it has been approved in multiple indications. It has also been the highest-selling neurology brand for several years. As such, the company has tried using aggressive strategies to extend the brand’s lifecycle in order ... Read More
Key Steps for Successfully Replying to Dossier Queries
Here’s a strategy chart outlining the key steps for successfully replying to dossier queries. Understand the Inquiry: Review Dossier Contents: Identify Response Components: Organize Response Structure: Gather Supporting Information: Compliance Check: Clarity and Conciseness: Transparency and Honesty: Quality Assurance: Timely Submission: Follow-Up Protocol: Documentation and Recordkeeping: Read also: Resource Person: ... Read More
Base Line Noise in HPLC
While performing HPLC analysis with an existing method, sometimes we will observe more base line noise. However, we won’t observe that scenario previously. The major probability due to: About dirty mobile phase: Grade of organic solvet used for analysis. Especially In case of THF is there in mobile phase we ... Read More
Comparison Between Generic and Branded Product Regulatory Filings
Generic and branded pharmaceutical companies both undergo regulatory filings as part of the drug approval process. While the overarching goal is to ensure safety and efficacy, there are distinct differences in the regulatory requirements and processes for generic versus branded medications. Regulatory Requirements Generic: Branded: Filing Process Generic: Branded: Timelines ... Read More
ASEAN Common Technical Document (ACTD)
It is a submission format for dossiers used in most ASEAN countries (Association of South-East Asian Nations). The main aim of ACTD is to regulate the pharmaceutical regulations of the ASEAN member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical ... Read More
ACCUTANE (Isotretinoin) | Drug Digest
ACCUTANE (isotretinoin) is indicated for the treatment of: Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the conditions listed above are unresponsive to conventional first line therapies. ACCUTANE should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who ... Read More
ANDA Suitability Petition Vs 505(b)(2)
Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman amendments, was enacted in 1984 to streamline the approval process for generic drugs. Under this law, generic drug manufacturers can file an ANDA to seek approval for a generic version of a previously approved brand-name drug, also ... Read More
Key Steps to Minimize the Chances of Getting a RTR from FDA
I am reaching out today to share important information that can help us circumvent any potential issues with Abbreviated New Drug Applications (ANDAs) filed with the FDA. ANDAs are essential for the marketing of generic drugs, and therefore receiving a Refusal to Receive (RTR) can significantly delay approvals. From detailed ... Read More
ANDA Submission and Common Deficiencies
In the world of pharmaceuticals, understanding the ANDA (Abbreviated New Drug Application) submission process is crucial for drug manufacturers seeking approval to market generic drugs. Evaluation Procedure The Food and Drug Administration (FDA) thoroughly evaluates each submitted ANDA to determine if it can be received for review. The concept of ... Read More