As reported in a recent Regulatory Focus article for the Regulatory Affairs Professionals Society (RAPS), officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP), confirming a fast-approaching deadline.Continue Reading
Despite the rapid rise in combination products over the past few years (an industry some predict to reach $115 billion by 2019), complex regulatory hurdles remain a persistent problem for firms bringing these new products to market.
Approving a combination product is anything but simple. Manufacturers must meet the requirements of a product's biologic and device requirements, naturally opening the door to a myriad of compliance risks.Continue Reading
Join Larry Stevens, RAC for a free webinar presentation covering the major topics of quality system harmonization.
Larry has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.
In this webinar, Larry unpacks the big decisions that lie ahead of company leaders before and during a merger, acquisition, or technology transfer and presents a model for companies to follow.Continue Reading
WESTBOROUGH, MA, August 31, 2017 -- Vault recently ranked The FDA Group No. 18 on its annual ranking for Best Consulting Firms for Work/Life Balance, an exclusive ranking of North America’s best consulting firms. Vault’s rankings are based on exclusive insider information from verified employees in the consulting industry. Each year, Vault surveys thousands of consulting professionals. From these results, Vault ranks the top consulting firms in prestige, quality of life, and overall best to work for.Continue Reading
WESTBOROUGH, MA, August 31, 2017 -- Inc. Magazine recently ranked The FDA Group No. 782 on its 36th annual Inc. 5000, the most prestigious ranking of the nation's fastest-growing private companies. The list represents a unique look at the most successful companies within the American economy’s most dynamic segment— its independent small and mid-sized businesses. Companies such as Microsoft, Dell, Domino’s Pizza, Pandora, Timberland, LinkedIn, Yelp, Zillow, and many other well-known names gained their first national exposure as honorees of the Inc. 5000.
On October 1, 2017, FDA FYI 2018 MDUFA User Fees (Medical Device application filing fees) will see a sharp price increase.
Especially striking is the introduction of fees for De Novo submissions, which will now bring a high price tag.
Here's a summary of just how much more these fees will cost.Continue Reading