05-Mar-2012 By Nick Taylor
Amgen has called FDA draft guidance on API-excipient co-crystals unnecessary in its written response to the Agency.
01-Mar-2012 By Nick Taylor
A US contract testing laboratory has received a FDA warning letter for allowing all its employees to use the same username and password.
01-Mar-2012 By Nick Taylor
The FDA has raised its limit on the bead size for drugs delivered by sprinkling after big pharma firms criticised its draft guidance.
29-Feb-2012 By Nick Taylor
The US FDA has sent APP Pharmaceuticals a warning letter after insects were found in production areas and finished products.
27-Feb-2012 By Nick Taylor
Sole suppliers that outsource manufacture must alert the FDA of interruptions at their CMOs, the Agency wrote in draft drug shortages guidance.
FDA issues import alerts against 22 Chinese heparin suppliers
23-Feb-2012
The US FDA has issued import alerts against 22 Chinese heparin suppliers it claims ship adulterated product.
23-Feb-2012 By Nick Taylor
The US FDA has published draft guidance on drug shortages to clarify when and how manufacturers should report possible supply disruptions.
22-Feb-2012 By Nick Taylor
The US FDA is allowing Sun Pharma to import a version of Doxil to ease the drug shortage created by manufacturing failings at Ben Venue.
16-Feb-2012 By Nick Taylor
The US FDA has sent West-Ward Pharmaceuticals a warning letter and asked for forewarning of any actions that may worsen drug shortages.
15-Feb-2012 By Nick Taylor
Regulations have failed to keep pace with modern understanding about manufacturing and quality, a FDA director said.
15-Feb-2012 By Nick Taylor
The US FDA expects Merck KGaA to do a “comprehensive and global assessment” of its sites after sending a warning letter to three plants.
14-Feb-2012 By Nick Taylor
The FDA has said it is critical that trade secret laws are changed to allow it to share manufacturing information with other regulators.
13-Feb-2012 By Nick Taylor
The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance.
02-Feb-2012 By Nick Taylor
The US FDA has called for more authority to ensure any track-and-trace system is binding for industry and pre-empts state laws.
31-Jan-2012 By Nick Taylor
The FDA has hit Novartis with another 483 after finding seven repeat observations and a backlog of 1,360 overdue consumer complaints.
26-Jan-2012 By Nick Taylor
The US has filed a “groundbreaking” injunction against Ranbaxy to force the generic giant to make “fundamental changes” at its plants.
19-Jan-2012 By Nick Taylor
The FDA has published a QbD approach to modified release tablet development to help generic companies meet its 2013 deadline.
17-Jan-2012 By Nick Taylor
The US FDA plans to study foreign regulators’ GMP inspection reports with a view to using them to support its enforcement efforts.
16-Jan-2012 By Nick Taylor
The US FDA has sent its generic user fee recommendations to Congress ahead of a meeting to discuss the plan next month.
05-Jan-2012 By Gareth Macdonald
The US Food and Drug Administration (FDA) will soon start asking drugmakers to play a greater role in guideline development. Before that process begins in-Pharmatechnologist.com takes a look at the documents published by the agency in 2011.
04-Jan-2012 By Nick Taylor
The FDA should encourage industry to submit draft guidance to speed regulatory development, an agency working group found.
22-Dec-2011 By Nick Taylor
The US FDA is seeking information to help it protect celiac disease patients from pharma ingredients derived from wheat, barley, or rye.
PhRMA backs FDA plans for biosimilar fees discussion
07-Dec-2011 By Gareth Macdonald
US drug industry group PhRMA has backed FDA plans to discuss fees for biosimilars with pharmaceutical manufacturers.
FDA releases draft co-crystal guidance to support NDAs
05-Dec-2011 By Nick Taylor
The US FDA has published draft guidance to help companies submit marketing applications for API-excipient co-crystals.
Ranbaxy forms pact with Teva to launch generic Lipitor in US
01-Dec-2011
Ranbaxy has introduced generic Lipitor in the US after partnering with Teva and gaining FDA approval for manufacture at its US plant.
FDA anti-adulteration efforts hindered by industry; GAO
28-Nov-2011 By Nick Taylor
Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.
FDA nanomaterial draft guidance means pointless extra regulation, say experts
22-Nov-2011 By Natalie Morrison
FDA draft guidance defines nanoparticles too broadly and could result in APIs being categorised as nanomaterials, industry said.
21-Nov-2011 By Nick Taylor
Real-time release testing can save money by cutting recalls but “fear of the unknown” is limiting use, a FDA official said.
FDA sends Genentech 483 after finding failings at Avastin plant
08-Nov-2011 By Nick Taylor
The US FDA has sent Genentech a GMP 483 after inspectors found failings in the capping process for Avastin.
FDA updates ICH Q&A to clarify design space requirements
07-Nov-2011 By Nick Taylor
The US FDA has updated its ICH Q8, Q9 and Q10 question and answer document to clarify design space requirements.
FDA plans QbD for clinical trials to cut industry & regulatory monitoring costs
24-Oct-2011 By Nick Taylor
The FDA is working on quality-by-design (QbD) for clinical trials to cut oversight costs for industry and regulators.
GSK hit with warning letter as FDA finds faults with UK site
19-Oct-2011 By Nick Taylor
The FDA has sent GSK a GMP warning letter after finding failings in steps to prevent microbiological contamination at a UK site.
FDA releases final guidance on anti-counterfeiting excipients
12-Oct-2011 By Nick Taylor
The FDA has published final guidance on the use of excipients as anti-counterfeiting tools in solid oral dosage forms.
Inspection data to be opened up in FDA transparency plan
04-Oct-2011 By Nick Taylor
The US FDA may add product and violation-specific searches to its publicly available database of inspections as part of a transparency push.
29-Sep-2011 By Nick Taylor
The US FDA has filed a permanent injunction against a US drugmaker and sent a warning letter to a Chinese API producer following cGMP problems.
FDA hits Indian API plant with warning letter & import alert
22-Sep-2011 By Nick Taylor
The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.
Reformulation targeted in FDA unapproved drug plan
20-Sep-2011 By Nick Taylor
The FDA is targeting companies that reformulate drugs to evade enforcement as it tries to crackdown on the 1000s of products marketed without approval.
Lonza MA plant sent FDA GMP warning letter about Eisai API
14-Sep-2011 By Nick Taylor
The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.
Risk-based, centralised trial monitoring wanted by FDA
30-Aug-2011 By Nick Taylor
The FDA is encouraging sponsors to use innovative approaches to lessen reliance on on-site trial monitoring in draft guidance.
Cost-cutting tablet splitting prompts FDA guidance
30-Aug-2011 By Nick Taylor
The rise of tablet splitting has prompted the FDA to advise manufacturers on what data is needed to support applications for scored doses.
18-Aug-2011 By Nick Taylor
The US FDA has warned that rapid patient enrolment in emerging markets can overload sites that lack the staff to oversee data as it is generated.
Biosimilar assessment a goal of FDA modernisation plan
18-Aug-2011 By Nick Taylor
The FDA is prioritising development of technologies to compare biosimilars to innovator products in its plan to modernise regulatory science.
Novel nasal implant from Intersect is winner for US FDA
17-Aug-2011 By Natalie Morrison
Intersect have received the FDA seal of approval of their targeted drug delivery technology for treatment in chronic sinusitis patients.
FDA says Cetero faked docs, manipulated samples at lab
28-Jul-2011 By Nick Taylor
Sponsors face having to redo lab work after the FDA alleged Cetero falsified records and manipulated samples to meet acceptance criteria.
FDA must be empowered to oversee supply chain; report
13-Jul-2011 By Nick Taylor
Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.
FDA offers grant to improve biopharm production steps
13-Jul-2011 By Nick Taylor
The FDA is offering a grant to research projects that improve the reliability, speed and quality of biopharm production processes.
Cadila sent warning letter after FDA finds microbiology probs
07-Jul-2011 By Nick Taylor
The FDA has sent a warning letter to Cadila Healthcare’s Ahmedabad, India finished products plant after an inspection found GMP deviations.
Tech & collaboration central to FDA's import quality plan
22-Jun-2011 By Nick Taylor
The FDA has outlined its plan to ensure the quality of products imported into the US, including working more closely with regulators and industry.
21-Jun-2011 By Nick Taylor
The EMA has proposed to the FDA that European inspections of US manufacturing plants are waived when certain criteria are met.
FDA sends warning letter to Dr Reddy's API Mexican plant
20-Jun-2011 By Nick Taylor
Dr Reddy's Mexican API production plant has received an FDA warning letter that details failures to validate analytical methods and other problems.