 FDA’s Hamburg Testifies on Patient Protection, User FeesFDA Commissioner Margaret Hamburg told a Senate appropriations subcommittee Tuesday that an increase of $101 million in funding — $51 million of
which would come from two new user fees — is needed to finance the agency’s Protecting Patients Initiative. Read More
Chinese API Supplier Cited for Not Detecting Altered DataThe FDA has warned Xian Libang Pharmaceutical,
a maker of active pharmaceutical ingredients (APIs), because its quality control unit failed to detect that an employee had manipulated testing data on
incoming raw materials. Read More
FDA to Test Recall Template to Communicate RisksThe FDA will test a new standardized template to quickly
and clearly communicate risk to consumers during the next big recall. Read More
Legal, Technical Challenges Slow Patient Recruitment Via EHRsA new disclosure rule, part of a broad effort under the American Recovery and Reinvestment Act to expand privacy and security relating to personal
electronic health records (EHRs), went into full force this month, requiring most research sites to report unauthorized acquisition, access, use or disclosure
of personal health information. Read More
Advisory Panel to Reconsider Clearance for MenaflexThe FDA has asked the
Orthopedic and Rehabilitation Devices Panel to reconsider the 510(k) clearance of ReGen Biologics’ Menaflex collagen scaffold
March 23. Read More
Supreme Court to Consider Liability for Vaccine MakersThe U.S. Supreme Court has agreed to hear a case
on whether the federal National Childhood Vaccine Injury Act (NCVIA) preempts all design-defect claims against vaccine manufacturers, regardless of whether
the side effects were unavoidable. Read More
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Legal, Technical Challenges Slow Patient Recruitment Via EHRsA new disclosure rule, part of a broad effort under the American Recovery and Reinvestment Act to expand privacy and security relating to personal
electronic health records (EHRs), went into full force this month, requiring most research sites to report unauthorized acquisition, access, use or disclosure
of personal health information. Read More
Advisory Panel to Reconsider Clearance for MenaflexThe FDA has asked the
Orthopedic and Rehabilitation Devices Panel to reconsider the 510(k) clearance of ReGen Biologics’ Menaflex collagen scaffold
March 23. Read More
Cardiac Science Updates Software Following FDA Warning LetterCardiac Science is providing customers with a new software update after the FDA told the company in a Feb. 5 warning letter that
its previous update would not prevent failures of its Powerheart automated external defibrillators. Read More
IOM: Lack of Statistical Data Hindering 510(k) ReviewCiting a lack of statistics
from CDRH, an Institute of Medicine (IOM) committee charged with reviewing the 510(k) process is turning to data from devicemakers and other healthcare
groups to fill in the gaps. Read More
FDA Proposes Rule to Curb Falsified Data in TrialsSponsors that learn their clinical trial data or its analysis may have been falsified must report the information to the FDA within 45 days under
a new proposed rule. Read More
Company Officials May Be Held Liable as FDA Steps Up Its ProsecutionsThe
FDA plans to increase prosecutions against corporate officials as part of its drive to improve its Office of Criminal Investigations (OCI), Commissioner
Margaret Hamburg said in a letter to Sen. Chuck Grassley (R-Iowa) last week. Read More
Chinese API Supplier Cited for Not Detecting Altered DataThe FDA has warned Xian Libang Pharmaceutical,
a maker of active pharmaceutical ingredients (APIs), because its quality control unit failed to detect that an employee had manipulated testing data on
incoming raw materials. Read More
FDA to Test Recall Template to Communicate RisksThe FDA will test a new standardized template to quickly
and clearly communicate risk to consumers during the next big recall. Read More
Supreme Court to Consider Liability for Vaccine MakersThe U.S. Supreme Court has agreed to hear a case
on whether the federal National Childhood Vaccine Injury Act (NCVIA) preempts all design-defect claims against vaccine manufacturers, regardless of whether
the side effects were unavoidable. Read More
FDA Sets Deadline for Makers of Unapproved NarcoticThe FDA has informed six generic-drug makers that they will face enforcement action after July 24 unless they stop shipping an unapproved morphine sulfate
oral solution or submit a supplemental NDA for the product. Read More
Sponsors Get FDA’s Thinking on Adaptive Trial ProtocolsThe FDA has proposed the first draft guidance on adaptive design protocols for clinical
trials, including details for standard operating procedures, methods for controlling bias in the studies and encouraging sponsors to have early meetings
with the agency. Read More
Compliance Boot Camp 2010
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