ReNeuron remains confident that its new stem cell therapy for
stroke will be approved to start clinical trials, despite a request
for further information from the industry regulator.
A federal court judge has imposed a temporary injunction against
the US Food and Drug Administration (FDA) over the organisation's
drug 'pedigree' requirements, on the basis that the regulations
leave sections of the...
Pharma company Medichem has announced it has passed a US Food and
Drug Administration (FDA) inspection without any problem for the
third consecutive time.
The US Food and Drug Administration (FDA) has decided against
restricting the use of drug-eluting cardiac stents after a two-day
investigation into their potential to increase blood clots.
The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.
The US Food and Drug Administration (FDA) and the pharmaceutical
industry are in strong negotiations to decide how much drug
companies will pay the agency to review new drugs from the end of
next year, when the current law expires.
The US Food and Drug Administration (FDA) has announced the launch
of a new guidance to help drug makers evaluate lab test results
that fall outside the specification limits.
Fewer first cycle new drug approvals by the US Food and Drug
Administration (FDA) could be the first evidence of a toughening
regulatory environment, according to new research.
The US pharmaceutical industry could be wasting more than $50bn
(€39bn) per year in manufacturing costs due to inefficient
processes, a new research has warned.
The US Food and Drug Administration (FDA) has admitted that more
needs to be done to ensure the safe and effective use of
prescription drugs, after a report urged the regulator to revamp
its drug safety system.
The US Food and Drug Administration (FDA) has come under scrutiny
after an independent report urged the regulator to implement large
reforms to ensure the safety of new prescription drugs.
Drug manufacturers can better understand how they can achieve
regulatory compliance and avoid production stoppages and recalls by
following new guidance issued by the US Food and Drug
Administration (FDA).
The US Food and Drug Administration (FDA) has censured three
American national pharmacies for using the traditional practice of
compounding as a ruse in order to operate as drug manufacturers,
producing thousands of unapproved copies...
The Food and Drug Administration (FDA) will beef up its process for
disclosing the conflicts of interest of its advisory experts in a
bid to restore its reputation after a survey suggests its
scientists may be too closely tied with...
In a controversial move, the US Food and Drug Administration (FDA)
has given the final nod of approval to pharma companies who want to
add colourful pearlescent pigments to their drugs to give them that
"special something."
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has signalled it will
soon allow a new "adaptive" approach to clinical trials in order to
streamline drug testing and speed drugs to market.
A report on the US Food and Drug Administration's (FDA) enforcement
record by US Democratic lawmakers has highlighted a plunge in the
number of warning letters the agency has sent to drug manufacturers
since 2000, citing several...
The first revisions to the layout of drug package inserts in 25
years will come into effect as of June 30 and the Food and Drug
Administration (FDA) has released a draft technical document to
help drug manufacturers incorporate the...
While praising the benefits of radio-frequency identification
(RFID), the US Food and Drug Administration (FDA) has refrained
from demanding its implementation in new measures it unveiled to
combat counterfeit drugs, asking instead...
In a scathing letter to Wyeth, the US Food and Drug Administration
(FDA) has vehemently criticised the drugmaker's manufacturing
operations in Puerto Rico, accusing it of failing to report
failures even when it was aware of them.
RSSL Pharma Training has established three new courses to help UK
pharmaceutical and medical device manufacturers prepare themselves
for a plant inspection by the US Food and Drug Administration
(FDA).
The move to make pharmaceutical companies more open to scrutiny has
taken a new direction as the US Food and Drug Administration (FDA)
moves to adopt a system that will allow the electronic coding of
crucial terms used in prescription...
Outsourcing-Pharma focus on: Phase IIIB-IV research
The US Food & Drug Administration (FDA) is investigating ways
of boosting the completion rate of new drug post marketing
commitment studies in the wake of ongoing controversy over the
agency's lack of enforcement. The answer,...
The US Food and Drug Administration (FDA) has linked its
Counterfeit Alert Network (CAN) to SafeMeds Alert System, an
electronic mailing list backed by pharmaceutical manufacturers that
sends warnings about fake drugs to anyone who...
Global medical technology company Gambro has had imports of its
kidney dialysis monitors into the US blocked by the US Food and
Drug Administration (FDA) after a failed plant inspection in
September.
Patheon has resumed normal production of Omnicef antibiotic powder
after it voluntarily suspended production in September at it
facility in Carolina, Puerto Rico, due to a US Food and Drug
Administration (FDA) manufacturing warning.
A federal US judge set a precedent last week in ruling against the
US Food & Drug Administration (FDA) in a four-year dispute
against Utah Medical Products.
A healthcare facility the US has been cleared by the Food and Drug
Administration to manufacture high-strength fludeoxyglucose F 18, a
drug used for diagnostic imaging with positron emission tomography
(PET).
The US Food and Drug Administration (FDA) has found itself once
again without a permanent Commissioner after the current incumbent
- Lester Crawford - resigned after 18 months in the post.
The US Food and Drug Administration (FDA) has drafted a current
Good Manufacturing Practice (cGMP) regulation for the production of
drugs used in positron emission tomography (PET), a diagnostic
tool.
Sandoz, the generic drug unit of Swiss pharmaceutical group
Novartis, has filed a law suit against the US Food and Drug
Administration (FDA) alleging that the agency is dragging its feet
in a review of a 'biogeneric' drug...
Quicker review times by the US Food and Drug Administration has not
increased the number of prescription drugs withdrawn for safety
reasons in the country, according to the Tufts Centre for the Study
of Drug Development.
Generics manufacturer Andrx Corp has become the latest generic
drugs manufacturer to fall foul of the US Food and Drug
Administration (FDA) because of quality issues at a manufacturing
plant.
Troubled generic drug manufacturer Able Laboratories has conceded
defeat in its bid to get products back onto the market and elected
to sell off the assets of the business.
The discovery of a new batch of counterfeit drugs circulating in
the US market adds urgency to ongoing efforts to improve
traceability in the medicines supply chain, and will also lend
weight to arguments against parallel trade in...
GlaxoSmithKline has signed a consent decree with the US Food and
Drug Administration to correct manufacturing deficiencies at its
Cidra, Puerto Rico facility, but could be in a position to return
two drugs made at the plant to market...
The US Food and Drug Administration (FDA), under fire of late for
an alleged failure to properly ensure prescription drug safety, set
out its stall at last week's Food and Drug Law Institute meeting,
saying that it is increasingly...
The controversy over the COX-2 inhibitor class refuses to die down
after the FDA asked Pfizer to withdraw Bextra (valdecoxib) from the
market because the overall risk of heart disease and
life-threatening skin reactions outweighed...
As part of an initiative to speed development of new medical
products through the science of pharmacogenomics, the Food and Drug
Administration (FDA) has issued a final guidance that aims to
clarify how pharmacogenomic data will be...
As the US Food and Drug Administration continues its deliberations
on generic biopharmaceuticals, the industry body representing
generic drug manufacturers has said that the time has now come for
the agency to make some hard decisions,...
A high-ranking US Food and Drug Administration official has told a
Senate advisory committee that the agency needs more authority to
force drug companies to change labelling for their drugs when
safety issues arise, writes Phil Taylor.
A new report suggests that recent safety concerns over certain
blockbuster drugs, notably Merck's Vioxx (rofecoxib) and Pfizer's
Celebrex (celecoxib), has placed the COX-2 inhibitor drug class
under intense scrutiny and...
The US Food and Drug Administration has published its long-awaiting
guidance on process analytical technology (PAT), aimed at
encouraging its use and raise the standard of manufacturing in the
pharmaceutical industry.
The US Food and Drug Administration will start using a risk-based
approach for prioritising site inspections for certain
pharmaceutical products, the agency has announced in a final report
on its current good manufacturing practice...
The US Food and Drug Administration has failed to reach a decision
on approving a growth hormone (hGH) product developed by Novartis'
generics subsidiary Sandoz in what is emerging as a test case for
the development of generic...
Calling the next six months 'a critical period', the US Food and
Drug Administration's Acting Commissioner Lester Crawford has
unveiled a lengthy list of agency priorities, including continued
work on Good Manufacturing...
A coalition of biopharmaceutical companies and regulatory agencies
has agreed on an electronic data standard that should make it
easier to file product approval dossiers to regulators
electronically, bringing drugs to market more...
The US Food and Drug Administration issued its final report on ways
to combat pharmaceutical counterfeiting and identifies
radiofrequency identification (RFID) as a primary means of tackling
the problem.
