<code id='37831E274A'></code><style id='37831E274A'></style>
      • <acronym id='37831E274A'></acronym>
      <center id='37831E274A'><center id='37831E274A'><tfoot id='37831E274A'></tfoot></center><abbr id='37831E274A'><dir id='37831E274A'><tfoot id='37831E274A'></tfoot><noframes id='37831E274A'>
      • <optgroup id='37831E274A'><strike id='37831E274A'><sup id='37831E274A'></sup></strike><code id='37831E274A'></code></optgroup>
        5. <b id='37831E274A'><label id='37831E274A'><select id='37831E274A'><dt id='37831E274A'><span id='37831E274A'></span></dt></select></label></b><u id='37831E274A'></u>
          <i id='37831E274A'><strike id='37831E274A'><tt id='37831E274A'><pre id='37831E274A'></pre></tt></strike></i>
           


   

   

   
   
   
   
   
   
   
   
   
   
   
   
   

   
   
   
   
   
   
   
  
           
  
           
  
           
   
           
    
           
     
           
      
           
       
      
           
      
           
       
           
        
           
         
           
           
          
           
         
           
         
           
           
          
           
         
           
          
        
           
       
           
       
           
        
           
        
           
        
           
        
           
       
           
      
           
       
      
           
      
           
       
           
       
           
       
           
       
           
        
           
        
          
          00:00 
        
           
       
           
       
           
      
           
      
           
        
        
        
       
           
        00:00 
         
        00:00 
        LIVE 
       
           
        
       
           
        
           
        
           
        
           
        
           
       
           
       
           
       
           
        
        
        
        
        
        
        
        
        
      
           
       
    
    
      
           
       
           
      
           
     
           
     
           
       
     
           
     
           
      
           
      
           
      
           
      
           
       
           
      
           
      
           
      
           
       
           
       
          
         buffering 
       
           
      
           
      
           
       
           
        
           
        
          
          Replay 
        
           
       
           
      
           
       
      
           
      
           
       
           
       
           
        
           
        
           
        
           
       
           
      
           
      
           
      
           
      
           
      
           
       
           
      
           
     
           
     
           
      
           
     
           
     
           
      
           
       
           
        
           
       
           
       
           
        
          
          LIVE 
        
           
        00:00 
         /  
        00:00 
       
           
       
           
        
           
        
           
        
           
         
           
         
           
         
           
         
           
         
           
         
           
        
           
        
           
        
           
       
           
       
           
        
           
        
          
          LIVE 
        
           
       
           
       
           
        
           
        
          
          CC 
        
           
       
           
       
           
        
           
       
           
       
           
       
           
        
           
        
           
         
           
        
           
       
           
       
           
        
           
       
           
      
           
      
           
       
           
        
           
        
           
         
           
         
           
         
           
          
           
          
           
          
           
         
           
        
           
       
           
      
           
      
           
       
           
     
       
           
    
       
           
       
    
  
       
           
   
       
           
       
       
           
      
           
      
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       Opacity : 
        
      
           
     
           
     
           
     
           
      
           
  
     
           
    
           
    
           
    
           
     
          
       Share: 
     
           
      
     
           
      
      Copy 
     
           
      
    
           
    
          
      Close 
      
    
           
    
           
      
    
           
    
           
   
           
  
           
  
           
    
    
    
   
           
   
           
 
    
   
           
   
           
   
           
    
           
     
           
      
           
       
           
        
           
          
          
         
          
          entertainment 

          
          
            
          
          

           
           
        
           
       
           
      
           
     
           
    
           
    
           
     
           
      
           
      
           

                       
          explore  
          
                                   
                 
                                      author：leisure time   
                                        
                                      
                                      -
 
browse：676
                                  
                                    
          
                                    
            
          
 
          insulin biosimilar
          The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests. 																									Jacquelyn Martin/AP
          A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests.
          The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests. When the FDA finalized its test regulation plan last month, several experts said it was only a matter of time until someone in the lab industry sued.
          advertisement
          Tests made in labs have historically gone unregulated by the FDA, as the agency considered them low-risk when it started regulating medical devices in 1976. But the tests have since become more numerous and complex, and the regulatory gray area enabled unreliable tests to thrive and harm patients. Infamous examples include Theranos’ blood tests, as well as misleading prenatal genetic tests from a range of companies.
          STAT+ Exclusive Story
          Already have an account? Log in
          STAT+
          This article is exclusive to STAT+ subscribers
          Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+.
          Already have an account? Log in
          Already have an account? Log in
          Monthly
          $39
          Totals $468 per year
          $39/month			Get Started			
          Totals $468 per year
          Starter
          $30
          for 3 months, then $39/month
          $30 for 3 months			Get Started			
          Then $39/month
          Annual
          $399
          Save 15%
          $399/year			Get Started			
          Save 15%
          11+ Users
          Custom
          Savings start at 25%!
          Request A Quote			Request A Quote			
          Savings start at 25%!
          2-10 Users
          $300
          Annually per user
          $300/year			Get Started			
          $300 Annually per user
          View All Plans																															
          Get unlimited access to award-winning journalism and exclusive events.					
          Subscribe																						Log In															
           
 
 
          

                              
          
                                 Previous article：

                                
                                          Activists slam private health insurers over coverage restrictions
                                
                            
          Next article：  
                                      
                                          5 wounded, 2 critically, in Michigan shopping center shooting
                                                                    
          

      
           
      
           
        
           
                                               
        
           knowledge 
           
                   
      
           
  
  
          
    
          
        
          
            
          
                                                     
                
          focus
          
                            
          
        
          
        
    
          

          

    

      
           
     
           


   
    
           
   
           
  
 

  
           
    
           
           
           
            
            Back To Top 
           
           
           
           

            
           
                                                                    
                 
          leisure time
           
                                      
            
           
          
           
                                                          
             
          focus
           
                             
            
           
            
           

                                                         
             
          Wikipedia
           
               
              
            
           
            
           
                                                         
             
          focus
           
                             
      
           
 
     
           
     
           
      
          
              STAT,APStockAstheBritishpoliticianBenjaminDisraelifamouslyobserved,therearelies,damnlies,andstatisti
             
           
      
          
        © 2013-2023.Company name All rights reserved.Site Map 
         WSS-More Templates  
             Guangdong ICP99name