Regulatoryinfo.org

Important Points to Know About New IND Safety Reporting …

WebIn 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. …

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URL: https://regulatoryinfo.org/important-points-to-know-about-new-ind-safety-reporting-guidance/

Upcoming Major Generic Drug Labeling Rule: What Should GDMs …

WebRecently FDA has confirmed announcement of a major and final rule of labeling coming in July 2016 that will entail new guidelines for updating labels of generic …

Category: Health Go Health

Labeling: Strategize and Streamline Processes to Meet Compliance …

WebPharmaceutical and medical device industries are constantly changing with developing supply chain themes and technological advancements due to which labeling …

Category: Medical Go Health

TGA Mandates Electronic Procedure for Certificate of Free Sale or

WebAccording to a recent announcement by the Therapeutic Goods Administration (TGA), sponsors of medical devices have a new procedure to follow for …

Category: Medical Go Health

Generics: FDA’s Record for Approvals and The New Guidance Drafts

WebDo you know? The United States Food and Drugs Administration (US FDA) has yet again set a new record for the number of generic drug approvals. In comparison …

Category: Food Go Health

Good Manufacturing Practice (GMP) – The Need and The Ways to …

WebBetween 10/1/2015 and 9/30/2016, the United States Food and Drug Administration (USFDA) through its system has issued almost 3905 483s to Biologics …

Category: Food Go Health

Will it be the end of dependency for generic drug manufacturers

WebThe US FDA’s proposed rule on Generic Drug Labeling: Explained The wait is over. In a recent announcement, the US FDA has asserted that the proposed rule of …

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Have you identified your critical DI and PI Data Sources for GUDID

WebFDA has established a unique device identification number (UDI) so as to suitably distinguish medical equipment through their usage and distribution. Even though …

Category: Medical Go Health

Borderline Medical Devices – Decode EC’s New Update on …

WebIn Europe, the demand for medical devices has increased by many folds. While medical device manufacturers are relying on the market demand, they must also …

Category: Medical Go Health

The Value of GxPs in Global Product Launch

WebOver the decades, with the inception of strict Regulatory regimes, life sciences companies have launched numerous medicinal products in the market …

Category: Health Go Health

New EU MDR – Timelines and Renewed Documentation …

WebOn April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) – 2017/745-MDR and 2017/746-IVDR, which have come to …

Category: Medical Go Health

TGA Approves New PI Form. Decode What It Entails.

WebTherapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on 8th November 2017. The …

Category: Health Go Health

Medical Writers Part 2: How to Handle Draft Preparation and …

WebIn the first part of this series, we discussed what actually a medical writer does. In this segment, we will talk in detail about the process of medical writing. Draft …

Category: Medical Go Health

The Final Safety Rule for Antibacterial Soaps – What manufacturers …

WebIn a recent announcement, the Food and Drug Administration (FDA) has established that the antiseptic wash products with certain (19 in number) active …

Category: Food Go Health

PSUR Submissions to be directed towards central repository at EMA

WebIn a recent update, it has come to light that the companies in the UK will no longer be submitting the Periodic Safety Update Reports (PSURs) to the national …

Category: Health Go Health

Nutraceuticals in the Global Arena & The Strategies Manufacturers

WebWide range of food products, dietary supplements and other health foods that are consumed to enhance the nutritional value of food are constantly growing, …

Category: Supplements, Nutrition, Food Go Health

DMA announces timelines to phase-in eCTD and VNeeS formats

WebThe latest announcement from the Danish Medicine Agency (DMA) specifically points out elimination plan for NeeS format and emphasizes the consequent …

Category: Medicine Go Health

QbD Paradigms: Regulatory Stimulant for Manufacturers

WebQuality by design (QbD) is based on sound science and quality risk management through which quality is built into products. Although the benefits of QbD …

Category: Health Go Health

Automation a Key Factor to Reduce Non-Compliance

WebThe term “regulatory compliance” takes on different definitions depending on the industry it is being applied to. But from an elevated level, compliance is all about …

Category: Health Go Health

Deriving value of Regulatory Consulting engagement

WebIn this article you will get to know about to deriving value out of your Regulatory Consulting & Regulatory Affairs consultant Services engagement. The Life …

Category: Health Go Health

Artwork Errors Affecting Enterprise Repute in Global Markets

WebThe dynamic environment of pharma regulatory for packaging artwork has set forth huge challenges in front of pharmaceutical and life sciences companies in terms …

Category: Health Go Health

Developing and Sustaining Right First Time Artwork Capabilities

WebArtwork design is an essential process in the supply of a pharmaceutical product which basically ensures patient safety while reducing recall risk. Artwork and …

Category: Health Go Health