INDUSTRY BUZZ

FDA Watch: Changes to CBER Email Policy May Affect Your Lab

Heads up to any lab that’s subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on Oct. 1 and from now on will send emails containing regulatory information only to recipients with secure email accounts. If your email account isn’t up to CBER standards, you’re likely to miss out on crucial communications.

Which Labs Are at Risk
Under the new policy, CBER requires an email address with a unique domain name to consider a recipient a “secure email partner.” As a result, the CBER will not send emails containing regulatory information to your lab if it uses as its business communications email:

  • An ISP email address such as Comcast.net or Verizon.net;
  • Gmail or Yahoo for email; or
  • A personal email account like Gmail.

Creating a New Account
Bottom line: If your email address doesn’t include a unique domain name, and you wish to continue to receive regulatory information from CBER via email, you’ll have to create a new account. This isn’t as difficult as it may sound. Gmail for Business, Office 365, and others offer secure hosted solutions. Outlook 2016 running on Windows 10 or Mac Sierra is another option.

Security Settings
However, simply creating an account with a unique domain isn’t enough. Security settings must meet FDA secure email guidelines. These guidelines can be found here.  If you’re not tech savvy or feel overwhelmed by the instructions, you can contact the FDA for assistance by using one of the email addresses provided.

Other Communication
It’s important to note that while a secure email address is required to receive and send regulatory communication from and to CBER, general communication that isn’t regulatory in nature, e.g., driving directions to the FDA campus, may be sent by unsecure email.

For technophobes who wish to continue to receive regulatory information, there’s another option: CBER will send hard copies of this communication via the U.S. Postal Service upon request.

FDA Approvals
Here’s a look at some of the key FDA approvals announced at the end of September through the third week of October:

NEW FDA APPROVALS
Manufacturer(s) Product(s)
Adaptive Biotechnologies De novo designation for clonoSEQ assay to detect and monitor minimal residual disease in patients with multiple myeloma and B-cell acute lymphoblastic leukemia
Myriad Genetics Approval of BRACAnalysis CDx for identifying HER2-negative, metastatic breast cancer patients with inherited BRCA1 and BRCA2 genetic mutations that may benefit from treatment with Pfizer’s Talzenna (talazoparib)
Progenika Biopharma Approval of ID Core XT molecular assay for blood donor and patient non-ABO red blood cell types for determining blood compatibility for blood transfusions
PerkinElmer Approval of NeoBase 2 Non-Derivatized MSMS kit for testing newborns for metabolic disorders with single dried blood spot
Applied BioCode 510(k) clearance for BioCode Gastrointestinal Pathogen Panel (GPP) with BioCode MDx-3000 molecular system
Qiagen Approval of expanded use of Therascreen EGFR RGQ PCR Kit as companion diagnostic for Pfizer’s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutation
Premier Biotech 510(k) clearance for oxycodone assay for use on its OralTox oral fluid-based drugs of abuse device
Premier Biotech 510(k) clearance for methadone assay for use on its OralTox oral fluid-based drugs of abuse device
Abbott Clearance for assay measuring magnesium in human serum, plasma or urine run on Abbott’s Architect c8000 clinical chemistry system
Siemens Healthineers Clearance for Innovance Free PS Ag assay for detecting free protein S antigen in human plasma collected from venous blood samples and running on Sysmex CS-5100 analyzer
Becton Dickinson Clearance for BD Phoenix Automated Microbiology System for rapid identification and determination of antimicrobial susceptibility of gram-negative Enterobacteriaceae and non-Enterobacteriaceae bacteria
Becton Dickinson Clearance for BD Phoenix CPO Detect confirmatory test to phenotypically detect carbapenemase-production in Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumanniion gram-negative ID/AST or AST-only Phoenix panels
Roche Clearance for  Elecsys FT4 III Assay for measurement of free thyroxine used to diagnose and treat thyroid disease
Skyla Clearance for Hi Hemoglobin A1c System (consisting of Hi Analyzer and Hi Hemoglobin A1c Reagent Kit) for measuring percent concentration of glycated hemoglobin in venous and finger-stick capillary whole blood
Princeton BioMeditech Clearance for BioSign Flu A+B test to detect influenza type A- and B-nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasalpharyngeal aspirate specimens

New CE Marks & Global Certifications

Notable European CE certifications:

NEW CE CERTIFICATIONS IN EUROPE
Manufacturer(s) Product(s)
Co-Diagnostics CE-IVD marking for Logix Smart Zika screening test
DiaSorin CE marking for Simplexa Group B Strep Direct molecular assay for use on firm’s Liaison MDx instrument
DiaSorin CE marking for its Simplexa VZV Direct Assay for detection of varicella-zoster virus that causes chickenpox and shingles from cerebrospinal fluid
Thermo Fisher Scientific CE-IVD marking for Oncomine Dx Target Test NGS-based assay detecting cancer-driver gene variants
Becton Dickinson CE-IVD marking for BD Max MDR-TB panel to detect tuberculosis-causing bacteria and mutations associated with resistance to isoniazid and rifampicin
Bioneer CE-IVD marking for HIV-1 kit for quantifying RNA in blood samples run on firm’s ExiStation system
Abbott CE marking for announced today that High Sensitive Troponin-I blood test

Other international clearances announced during the period:

NEW FDA APPROVALS
Manufacturer(s) Country(ies) Product(s)
AmoyDx South Korea Ministry of Food and Drug Safety approval for ROS1 fusion assay as companion diagnostic for Pfizer’s non-small cell lung cancer (NSCLC) drug Xalkori (crizotinib)
Invivoscribe Japan   Pharmaceuticals and Medical Devices Agency approval for LeukoStrat CDx FLT3 Mutation Assay companion diagnostic
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