Pharma Blog
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
Effective Design of Clinical Trials | FDA
The 1962 FD&C Act Prior to 1962, drug safety was the primary concern, but the act revolutionized the landscape by demanding substantial evidence of a drug’s effectiveness. This shift led to the requirement of “adequate and well-controlled studies” – a cornerstone of modern clinical research. 𝗔𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝗮𝗻𝗱 𝗪𝗲𝗹𝗹-𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: 𝗧𝗵𝗲 ... Read More
Stability Data and Evaluation of Finished Pharmaceutical Products
Stability Studies: A Brief Introduction Stability studies are crucial for determining the shelf life and storage conditions of pharmaceutical products, ensuring their efficacy and safety throughout their lifespan. Long-term and accelerated studies are conducted to evaluate how products respond to various environmental conditions. Data from these studies help establish expiration ... Read More
Role of pKa and pH Values in HPLC
One of the critical factors influencing the success of an HPLC analysis is the control of pH, which directly impacts the ionization state of analytes. The pKa value of a compound, indicating its acid dissociation constant, plays a pivotal role in this process. pKa: A Key Parameter The pKa value ... Read More
Choice of Analytical Techniques for Cleaning Validation
Visual Inspection: Visual Inspection is the examination of the dried equipment under suitable lighting conditions by personnel with appropriate standards of vision. Generally, it is used when it has been demonstrated that a calculated MACO would leave a visible residue as it is not intuitive that a validated method of ... Read More
Classification of Elemental Impurities
The elemental impurity classes are: Class 1: The elements, As, Cd, Hg, and Pb, are human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drug products typically comes from commonly used materials (e.g., mined excipients). Because of their unique nature, these four elements ... Read More