Background: Around 25% of the drugs being imported into the US are manufactured in India and in the past few years Indian drug makers were not being audit under tight compliance by the FDA. But due to some recent mishaps and bad experiences with some Indian companies like Ranbaxy and Wockhardt, the FDA has decided
This is to announce that Alan P. Schwartz, Executive VP, mdi Consultants, Inc. has been invited to join the Editorial Advisory Board of MDT (Medical Device Technology). Alan has also been on the Editoral Advisory Board of GXP for over 10 years.
Present Scenario: The US Food and Drug administration is appealing for feedback on its proposal to bring into line its medical device labeling requirements with those in the EU by permitting the use of standardized stand alone symbols on device labels providing these are clarified in a supplementary symbols glossary. Regulations in the US at
Background: The Department of Health and Human Services (HHS), of which the Food and Drug Administration (FDA) is a part, recently published “Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations.” Essentially, this Plan is the SOP for how HHS and FDA will operate under the current partial government shutdown. Under this
Physician Payment Sunshine Act Clients will be interested to know that American Medical Association (AMA) being the only governing body for physicians has come up with this new act called as Physician Payment Sunshine Act. This act demands the manufacturers of drugs, medical devices and biologics to record certain items and payments they have made
In the future, you will be able to submit applications to Health Canada through the US Food and Drug Administration’s gateway. Health Canada is collaborating with its U.S. regulatory counterparts to reduce regulatory burden for health products, and to move closer to an automated environment for the exchange, review and management of information supporting the
LOK-RUS and mdi Consultants Inc. are pleased to announce a strategic alliance. LOK-RUS provide services to the Russian Market including Registration, Translation, Manufacturer Agent & Local Authorized Agent Representation and aim to offer our customers access to other predominant markets as well. mdi Consultants Inc. is a leading provider of quality assurance, regulatory compliance and
An Unexplored Opportunity for Pharmaceutical and Medical Device Industries December 4-7, 2012 Alan Schwartz, Executive VP, & Aditya Sukthankar, Associate mdi Consultants Inc., Great Neck, NY, USA Five years ago, U.S. Agency for International Development (USAID) asked mdi Consultants to visit Nicaragua to review the country’s industries, evaluate their potential for expanding the investment and
FDA compliance has been much more difficult to deal with By Alan Schwartz What is going on with the FDA? Is the FDA on a war-path judging by the ever increasing number of facility inspections? Or is it like any bureaucracy, they have taken on too much work without clearly assessing the consequences for companies,
Recently, there was a warning letter issued to a company (dated Sept 11, 2012) that was registered as a “specification developer” with the FDA. The inspection of the company was conducted by the FDA on June 7, 2012. However, this article is not about the company and what they manufactured or what they distributed. This
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