FDApals provide US FDA Agent Service that is full solution for helping you navigate the complex and confusing FDA process. We will help you with all aspects of your product, from initial marketing strategy to regulatory compliance. Our FDA Agents are trained professionals who have years of experience working with the FDA, and we will guide you through every step of the process so you can focus on what you do best: running your business. We understand how important it is to stay compliant with FDA Regulations, which is why we offer our services at an affordable rate. We also have several pack ..read more

The cosmetic industry, a realm that significantly influences daily life and wellness, has entered a new era of regulation and safety standards with the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This pivotal legislation, the most substantial update since the Federal Food, Drug, and Cosmetic Act of 1938, revolutionizes the way cosmetic products are regulated in the United States, signaling a paradigm shift in product safety and consumer assurance. The Need for MoCRA: A Historical Perspective For decades, the cosmetics industry has operated under relatively len ..read more

Modernization of Cosmetics Regulation Act of 2022 ( MoCRA) Background: The average American uses 6 to 12 cosmetic products daily, including makeup, nail polishes, shaving creams, perfumes, cleansers, haircare products, moisturizers, and more. MoCRA addresses the need for more robust regulatory oversight of these widely used products. Key Definitions: MoCRA introduces specific terms such as “adverse event,” “facility,” “responsible person,” and “serious adverse event.” These terms define the entities and circumstances under which regulatory measures apply. New Authorities for the FDA: The act ..read more

Pharmaceutical Primary Packaging material Packaging plays a crucial role in the pharma Industry by providing barrier protection to products for the shelf-life period. It is increasingly playing a vital role in ensuring overall patient safety by carrying key information pertaining to the product, ensuring tamper- evidence, and traceability of products. Pharmaceutical packaging is usually the economic means of providing presentation, protection, identification, information, convenience, integrity, and stability of the product. Indian Pharmaceutical Packaging Market can be understood by Products ..read more

As per the press note released by FDA , Maharashtra Food & Drugs Administration has cancelled the manufacturing license of Johnson’s Baby Powder of Johnson’s & Johnson’s Pvt. Ltd. FDA as a routine active do checks commercial samples from the market for quality and in one such incident they tested samples of  Johnson’s Baby Powder of Johnson’s & Johnson’s Pvt. Ltd. drawn from Pune and Nashik.  Testing data confirmed that the product didn’t comply to IS 5339:2004 standard requirement and it was failing with respect to PH Test. Johnson’s & Johnson’s Pvt. Ltd. challenged ..read more

An ANDA is a request by a drug manufacturer to market a generic version of an existing brand-name drug. Unlike unique, patented pharmaceuticals, generic drugs are not protected by patents, which means that they can be manufactured by anyone who wants to make them. In order to sell their product, however, the company must first apply to the FDA for approval. This application is called an ANDA—abbreviated from “Abbreviated New Drug Application The Food and Drug Administration (FDA) approves generic drugs through the Abbreviated New Drug Application (ANDA) process. This article will help you unde ..read more

Food facility registration or FDA food facility registration are what you should find when do you should starting your new business where sell or manufacture any type of food to human. This is help to declare which one is so that FDA have a record of them. The main purpose is to certify the facility, its employees and all equipment used in the company. There could be multiple reasons why food manufacturer must register with FDA. The Food and Drug Administration (FDA) defines a “food facility” as any operation that manufactures, processes, packs, or holds food for consumption in the United Sta ..read more

The FDA is responsible for regulating medical devices in the United States. This includes approving new devices, inspecting manufacturing facilities, and tracking post-market performance. If you are a manufacturer of medical devices, you must register with the Food and Drug Administration (FDA). The purpose of registration is to ensure that FDA receives accurate information about your company so that it can keep track of what is being manufactured and sold in the marketplace. The primary benefit of registering with the FDA is that manufacturers can make claims about their products that have ..read more

Are you looking for a reputable medical device FDA Registration service to assist you in your gadget regulatory submission? We are a group of dedicated professionals with more than five years of experience in the global medical devices industry and over 16 years of experience in medical industry as a whole. For healthcare providers and medical device manufacturers, getting registered with the FDA is not a simple task. However, it is a crucial step in moving your medical device to market. That’s why we’ve created a blog to help you register your medical device with the Food and Drug Administrat ..read more

FDApals provide US FDA Agent Service that is full solution for helping you navigate the complex and confusing FDA process. We will help you with all aspects of your product, from initial marketing strategy to regulatory compliance. Our FDA Agents are trained professionals who have years of experience working with the FDA, and we will guide you through every step of the process so you can focus on what you do best: running your business. We understand how important it is to stay compliant with FDA Regulations, which is why we offer our services at an affordable rate. We also have several pack ..read more