Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval.
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January 19, 2021 Regulatory Affairs, Regulatory Medical Writing -
July 10, 2019 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsDrug development is no cakewalk. Pharmaceutical companies are obliged to prove drug safety and efficacy to Regulatory authorities at every single stage of drug development. Based on the authority’s approval or disapproval only, the companies can further go into later stages of drug development and/or can relook into the entire developmental process.
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April 19, 2017 Health Authority UpdatesAs said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The deadline for the first phase is on 5th May 2017 and for the second phase, it is on 5th May 2018. What’s there to reconsider now?
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April 4, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesEven though the eCTD (Electronic Common Technical Document) format has been in existence for nearly ten years, now it has become a focal point for pharmaceutical, biologic and generic drugs manufacturers because of the US FDA (Food & Drug Authority) mandate stating that all NDAs (New Drug Application), BLAs (Biologics License Applications) and ANDAs (Abbreviated New Drug Applications) must...
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February 28, 2017 Publishing & Submissions, Health Authority UpdatesAs we all are aware, the United States Food and Drug Administration’s (US FDA’s) electronic Common Technical Document (eCTD) requirement is nearing the deadline.
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November 30, 2016 Publishing & Submissions, Health Authority UpdatesAre you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
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July 20, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesDo you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
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June 16, 2016 Regulatory Software & Services, Health Authority UpdatesTimes when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming.
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Japan has a unique set of processes and agencies for the regulation of drugs. The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are the two main Regulatory Agencies that oversee the approvals of the drugs as per the regulatory prerequisites in Japan.
Investigational New Drug (IND) Filing Process
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January 25, 2016 Pharmaceutical, Regulatory Labeling, Health Authority UpdatesIn our last blog we talked about a Major Generic Drug Labeling Rule that will entail new guidelines for updating labels of generic drugs in terms of safety information. In this segment we are emphasizing on getaways from the guidance proposed by FDA with respect to safety assessment for IND Safety reporting.