In recent years there has been an unprecedented increase in the number of submissions of Abbreviated New Drug Applications (ANDAs) and 505 (b) (2) applications, mainly owing to the spurt in the number of follow-on insulins submitted via the 505 (b) (2) pathway and with a record increase of generic drug applications…
- November 3, 2017 Regulatory Affairs, Publishing & Submissions
- October 18, 2017 Regulatory Medical Writing
Are you a drug or biologics manufacturer willing to submit adverse event (AE) report with respect to your product to the United States Food and Drug Administration (USFDA)? Or are you a healthcare professional or a consumer planning to report AE or medication error to the US health agency and/or willing to access the safety information related to a specific drug? Then, here is an announcement for you.
- October 10, 2017 Regulatory Labeling, Health Authority Updates
Since 31st August 2016, the Therapeutic Goods Administration (TGA) is continuously working to update its guidelines for labeling of medicines supplied in Australia to ensure companies be aligned with international labeling best practices and reduce medication errors.
- September 29, 2017 Medical Devices
The US Food and Drug Administration (FDA) has announced that it may release finalised guidelines for the device changes that would need a new 510(K) submission before 8th November, 2017.
- September 26, 2017 Freyr Announcements
Going by the reports, the medical device market in Middle East is expected to reach US $ 31.6 billion by 2025. But the diversified culture in terms of ethnicity and language in addition to the developing Regulatory framework (in some countries), taping the Middle Eastern market potential, however, might be challenging for device manufacturers who are willing to register their products in the region.
- September 13, 2017 Medical Devices, Regulatory Consulting
Mexican Medical Device market is expected to reach $6.5 billion by 2020. Being the second largest market for medical devices in Latin America, Mexico offers a good bet of business opportunities.
- August 1, 2017 Regulatory Labeling, Regulatory Software & Services
It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements. Been effective from 31st Aug 2016, there have been continuous developments to the proposed labeling rules emphasizing the need to be aligned with international labeling best practices and reduce medication errors.
- July 4, 2017 Health Authority Updates
In its latest announcement, European Medicines Agency (EMA) informed the Industry Change Liaisons that it has formally approved P&SMS Iteration 1 project covering Identification of Medicinal Products (IDMP) compatible authorized Human and Veterinary Products and Substances Management Services.
- June 29, 2017 Medical Devices, Health Authority Updates
The regulations of the medical device industry in Europe may have remained relatively unchanged since the 1990s but recent upheavals such as the breast implant crisis and hip replacements resulted in immediate Regulatory reforms.
- June 20, 2017 Medical Devices, Health Authority Updates
Ever since the FDA rolled out UDI rule, it has faced major hiccups down the road. Increasing concerns of medical device companies over deadlines is one among them. In a recent announcement, FDA yet again informed the compliance dates for certain Class I and Unclassified medical devices have been further extended.