NNHPD Improvements to support NHP site licensing
What improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies
... Read more
May 12, 2023
[searchwp_form id=1]
[blog_list]
FTC puts nearly 700 companies on notice of product claim civil penalties
Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
... Read more
April 21, 2023
FDA to close VCRP to prepare for MOCRA registration in 2023
Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to
... Read more
April 4, 2023
FDA Registration Renewals: FDA Increases Facility Enforcement
As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
... Read more
March 22, 2023
Health Canada Medical Device License Renewals (MDL or MDEL) in 2023
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read more
March 22, 2023
FDA Fees for Medical Device Establishment Registration in 2023
The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023
... Read more
March 16, 2023
MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023
PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023. The
... Read more
March 7, 2023
MDR Amendments COVID-19 Medical Devices Importing & Sales
Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose, treat,
... Read more
March 7, 2023
Health Canada Labelling & Cosmetic Notification changes in 2023
Introduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following
... Read more
March 3, 2023
FDA Draft Guidance Labeling Plant Based Milk Alternatives in 2023
Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of
... Read more
February 22, 2023
Health Canada Latest Draft Guidance (Biologic Regulations, Drug Labelling, NDS/ANDS & Drug Submissions Rolling Reviews)
Introduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide
... Read more
February 22, 2023
FDA to tighten regulatory process around CBD food & supplements
Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
... Read more
January 27, 2023
Explore Health Canada’s Medical Device Regulations (MDL, MDEL & SaMD)
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
... Read more
December 8, 2022
5 FDA Warning Letters: Food Manufacturers of CBD Food Products
Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
... Read more
November 30, 2022
FDA UDI Labeling Requirements for FDA Class 1 Medical Device in 2023
Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
... Read more
November 16, 2022
CFIA Enforcement of Nutrition Facts Table & CFIA Labeling Requirements
The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
... Read more
November 9, 2022
FSVP Compliance: Regulatory Assessment Record Keeping 2023
U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
... Read more
November 7, 2022
Food Labelling & Health Canada Packaging Update for 2023
Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and
... Read more
November 3, 2022
Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
... Read more
November 1, 2022
Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know
Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
... Read more
September 9, 2022
Industry News
Search Search [searchwp_form id=1] [blog_list] 0/5 (0 Reviews)
... Read more
July 14, 2025