June 2012 | Full Issue in PDF Format
The Senate-passed omnibus FDA user fee bill includes a proposed track-and-track system, but lawmakers need to hammer out details with the agency and stakeholders or risk seeing the proposal jettisoned from a final bill.
Several drugmakers in China are being ordered to power down production lines and hand over their licenses for producing capsule-based drugs after a crackdown on chromium contamination by the country’s regulatory agency.
The FDA will not approve Alexza Pharmaceuticals’ drug-device combination product for agitation drug Adasuve until the company clears up manufacturing lapses outlined in a complete response letter (CRL).
Generic-drug makers are contributing to review delays because, intentionally or not, their ANDAs too often fail to provide a full list of personnel and facilities involved in drug manufacturing and testing, FDA officials say.
Ongoing remediation at Hospira’s Rocky Mount, N.C., plant is on track with the aid of new hires and consultants, the company says.
To promote more thorough ANDA filings and faster reviews, the FDA’s Office of Generic Drugs (OGD) plans to extend its quality-based review (QbR) process to Type II drug master file (DMF) submissions, FDA officials say.
Concerns about inadequate drug storage and quality training at Alexza’s Mountain View, Calif., facility were cited by FDA investigators just weeks before the company received a complete response letter (CRL) rejecting its combination product for agitation drug Adasuve, an FDA Form 483 states.
Quality control personnel at Millennium Pharmaceuticals’ Cambridge, Mass., facility failed to adequately investigate particles found in several lots of contract-manufactured Velcade, an injectable oncology drug, an FDA Form 483 states.
Citra Labs, a maker of injectable anticoagulants, received a lengthy, 28-observation Form 483 noting various visual inspection shortfalls, including a lack of a rejection limit for glass particles.
Agency inspectors found Impax Laboratories failed to reject drug products that did not meet established standards and specifications, an FDA Form 483 states, shedding light on the additional quality issues found at the company’s already troubled Hayward, Calif., facility.
After a warning letter and two failed inspections, the FDA called in the big guns, requesting that U.S. marshals seize an unapproved, misbranded scar removal drug marketed by Crescendo Therapeutics.
The FDA will probably take its time adopting an International Conference on Harmonisation (ICH) guideline that recommends drugmakers use risk assessments to identify material and process characteristics that could alter the critical quality attributes (CQAs) of active pharmaceutical ingredients (APIs).
FDA statistics show more than one-third of all drug recalls last year were due to stability failures — a figure that suggests the generic industry’s call for stability testing flexibility in a forthcoming guidance is unwarranted, agency officials say.
Genentech may need to tune up manufacturing practices at a San Francisco, Calif., plant that makes cancer drug Avastin.
Federal authorities have arrested 11 South Florida men in connection to multi-million dollar drug thefts at the warehouses of Eli Lilly in Connecticut, GlaxoSmithKline (GSK) in Virginia and others.
A new federal interim rule aims to help customs officials filter out fake drugs at the U.S. border by providing for the early release of commercially sensitive data to drugmakers that hold rights to incoming products.
Drugmakers breaking into emerging markets could see supply chain benefits and quicker product launches if these markets automatically registered FDA-approved products before testing for quality issues, according to a new study.
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