FDA Announces Agency Restructuring: A Change For The Better?
FDAImports.com has obtained a copy of some very recent email correspondence sent by U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg to her employees announcing her decision to restructure the agency’s top management tier. Although she cites...
Benjamin England to Present at RAPS Webinar: Imports and the FDA: Insight into Evolving Regulations
FDAImports.com Founder and CEO, Benjamin England, will be presenting at a RAPS webinar on July 20th, 2011 titled, "Imports and the FDA: Insight Into Evolving Regulations." This webinar will cover the changing landscape of FDA import...
FDAImports.com Fights for Eight Months for the Successful Removal of Client’s Soybean Product from U.S. Import Alert # 99-08, Automatic Detention
Months ago the expert consultants at FDAImports.com petitioned the U.S. Food and Drug Administration (FDA) to remove a Chinese processor of soybeans from Import Alert # 99-08, “Detention Without Physical Examination of Processed Foods for Pesticides.” FDA’s basis to...
U.S. Firm Offering Free FDA Regulatory Training Sessions in China? It’s a Win/Win.
Last week FDAImports.com and ExportToUsa.com.cn hosted a series of free FDA regulatory training sessions in Beijing and Shanghai, China for Chinese companies exporting FDA-regulated goods to the United States. Over 70 people attended the training sessions from over...
Imports From China: Takeaways From the 2011 FDLI Conference in Beijing, China
The Food and Drug Law Institute (FDLI) recently launched its first Chinese conference, US- China Food And Drug Law: Ensuring Quality, Improving Safety, Expanding Access. FDAImports.com, was represented at the conference by its CEO, Benjamin England, Mr. Rick Quinn,...
FDAImports.com Welcomes New Administration and Marketing Manager and Digital Communications Strategist
FDAImports.com recently welcomed two new staff members to its growing team. FDAImports.com recently hired Anne Lehan as the firm's Administration and Marketing Manager. Her role will be to oversee the financial, administrative and marketing functions of the...
CDER’s Restructuring will Likely Reduce FDA Transparency and Create Delays for Drug Importers
FDA’s Center for Drug Evaluation and Research (“CDER”) is establishing a new office, which in part will focus on drug importations. This move highlights CDER's increased involvement in determining the compliance of individual drug-shipments imported into the United...
FDA Clarifies its Concerns about Medical Devices from Japan
In a previous FDAImports.com article on the Japan Earthquake it was stated that FDA-regulated products from Japan will likely face many new hurdles in order to enter the United States. FDA will likely subject them to greater regulatory review by inspecting incoming...
FDA Steps Up Its Presence in China by Inspecting More Food Facilities
According to research done by www.FDAImports.com, The U.S. Food and Drug Administration (“FDA”) aggressively stepped-up the number of food facility inspections in China last year according to the FDA Inspection Classification Database. Between fiscal year 2009 and...
FDA Makes Database of Compliance Violators Available To Public
The FDA has recently made public and easily accessible several databases disclosing the results of FDA inspections for companies with compliance issues related to the Food, Drug and Cosmetic Act and results of criminal investigations and debarment actions along with...