![]() Sharfstein: FDA to Release Track-and-Trace GuidanceThe FDA plans to release a new guidance establishing
a standard for unique identification for prescription drug packages. Read More
Plaintiffs Claim Pfizer Papers May Reveal Delay of GenericsPlaintiffs in a class action antitrust lawsuit
against Pfizer are asking the U.S. District Court for the District of New Jersey to review company documents, saying they may show the drugmaker wrongfully
tried to delay generic competition for its epilepsy drug Neurontin. Read More
FDA, EMA to Simplify Submission of Orphan Drug Annual UpdatesThe FDA and the European Medicines Agency
(EMA) will allow sponsors to send a copy of the same orphan drug designation annual report to each agency. Read More
Abbott Molecular Gets 483 Listing Six ObservationsAbbott
Molecular’s Des Plaines, Ill., facility received six observations related to its hepatitis B virus (HBV) in vitro diagnostic. Read More
Industry: CDRH Science Initiative Needs to Be Consistent, ClarifiedFrom
calls for consistency and clarity to demands to end its unofficial “corrective fix” recall program, CDRH has received a docket full
of suggestions on how to integrate new science into its regulatory policies. Read More
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
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Abbott Molecular Gets 483 Listing Six ObservationsAbbott
Molecular’s Des Plaines, Ill., facility received six observations related to its hepatitis B virus (HBV) in vitro diagnostic. Read More
Industry: CDRH Science Initiative Needs to Be Consistent, ClarifiedFrom
calls for consistency and clarity to demands to end its unofficial “corrective fix” recall program, CDRH has received a docket full
of suggestions on how to integrate new science into its regulatory policies. 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
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
Plaintiffs Claim Pfizer Papers May Reveal Delay of GenericsPlaintiffs in a class action antitrust lawsuit
against Pfizer are asking the U.S. District Court for the District of New Jersey to review company documents, saying they may show the drugmaker wrongfully
tried to delay generic competition for its epilepsy drug Neurontin. Read More
FDA, EMA to Simplify Submission of Orphan Drug Annual UpdatesThe FDA and the European Medicines Agency
(EMA) will allow sponsors to send a copy of the same orphan drug designation annual report to each agency. Read More
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
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