The US Food and Drug Administration (FDA) has ordered the seizure of $74,000 worth of Xiadafil VIP tablets after SEI Pharmaceuticals refused to withdraw them from the market.
Ranbaxy’s CEO has confidently asserted that the US Food and Drug Administration’s (FDA) court action will be dropped in the near future and fired another warning shot at the “negative elements” he believes were behind the controversy.
Life science tools and services company MDS Inc has said it will cut about 210 jobs at two of its divisions - its MDS Pharma Services and MDS Analytical Technologies – in a bid to reduce costs by around $20m a year.
The US Food and Administration says that a new project examining the interaction between its review and facilities inspection arms will help improve inter-departmental communication, particularly during pre-approval inspections (PAI)
A US senator has asked the Food and Drug Administration (FDA) for a
probe into outsourcing of production for pharmaceuticals, as well
as ways to make drugmakers accountable for products which fail to
meet quality standards.
Michigan-based drugmaker Perrigo and Cobrek Pharmaceuticals, a
newly formed subsidiary of Pentech Pharmaceuticals, are teaming up
to develop a range of topical generic products for the dermatology
sector.
The FDA has issued US drug maker Scientific Laboratories with an
injunction preventing it from producing drugs until
manufacturing operations are brought up to code.
A heart medication sold by Mylan Laboratories in the US has had to
be recalled, after it emerged that some doses may contain twice the
intended dose of active ingredient.
The US Food and Drug Administration (FDA) has withdrawn its
long-standing block on the manufacture of new products at Watson
Pharmaceuticals' facility in Davie, Florida.
Frank Torti has been appointed to the newly created post of chief
scientist at the FDA, with a brief to "oversee, coordinate, and
ensure quality and regulatory focus of the intramural research
programs".
The US Food and Drug Administration (FDA) believes that the
contamination of Baxter's blood thinner heparin, which has been
linked to 62 deaths in the US, may have been due to the deliberate
replacement of some ingredients with...
Actavis has purchased a 90 per cent stake in Zhejiang Chiral
Medicine Chemicals (CMC), a Hangzhou, China-based active
pharmaceutical ingredients (API) maker.
The pharmacopoeias of the US and China will work more closely
together in future in a bid to improve the quality of medicines
available in both countries.
The US Food and Drug Administration (FDA) has defended its proposed
rule on product labelling changes made unilaterally through
"changes being effected" (CBE) supplements against
accusations from Congress, trial lawyers...
New research has shown that the FDA's strict 10-month deadline for
a drug's approval following submission may compromise drug safety
and lead to insufficient data for precise drug administration.
A US Food and Drug Administration (FDA) investigation into the
recent Baxter heparin scare has uncovered a contaminant in the
product that was sourcing the active pharmaceutical ingredient
(API) from a Chinese manufacturer.
The globalisation of the supply chain increasingly challenges the
US Food and Drug Administration's ability to ensure the quality of
pharmaceuticals on the US market, acknowledges the acting director
of the agency's Center...
More details have emerged over the US Food and Drug
Administration's (FDA's) failure to vet the Chinese manufacturing
plant implicated in the Baxter heparin scare - the agency mistook
it for an already-inspected plant, it...
An end may be in sight to the long-running problems with the
Florida manufacturing facility acquired by US brand and generic
company Watson Pharmaceuticals with Andrx Corporation in November
2006.
UK drug delivery specialist SkyePharma has signed an agreement with
India's Dr Reddy's Laboratories for a feasibility study of an
unnamed product using two of SkyePharma's proprietary drug delivery
systems.
A proposed rule on labelling changes published by the Food and Drug
Administration (FDA) has re-ignited the reliably inflammable debate
over the role of pre-emption in US product liability cases.
Discovery Laboratories could see the end of its struggle to launch
its Surfaxin (lucinactant) drug on the US market as it has finally
resolved the manufacturing issues that have plagued the product for
months.
The US Food and Drug Administration (FDA) has been called into
question again after the release of a damning report, this time
suggesting the agency is inadequate in its safety monitoring of
clinical trials.
Following the recent news that pharma heavyweight Pfizer has also
been struck by contamination of its HIV drug Viracept (nelfinavir),
in-PharmaTechnologist.com spoke to the US Food and Drug
Administration (FDA) to find out how far...
SkyePharma is looking towards a positive future despite a pre-tax
operating loss of £14.1m (€20.3m), announced in the UK company's
unaudited six-month results.
It seems that the ghost of the US Food and Drug Administration
(FDA) probe has stopped haunting MDS Pharma as the firm posted
encouraging financial results in the third quarter.
Adams Respiratory Therapeutics is positive about its plans to build
its prescription products portfolio after announcing its financial
results for the 2007 fourth quarter and year-end.
Indian pharmaceutical manufacturing company Shasun Chemicals and
Drugs has now got its eye fully on the US market after recent
approval of its new formulation facility in Puducherry.
Siemens is offering software support for the implementation of
Process Analytical Technology (PAT) in the pharmaceutical industry
with the launch of its Sipat package.
There are some areas of the European approval system
for biosimilars that still need to be clarified, a panel of
industry experts said during BIO 2007.
Contract manufacturer Granules India is moving towards vertical
integration, with a new tabletting facility scheduled to come
onstream this August at the company's Gagillapur site near
Hyderabad in India.
The US Biotechnology Industry Organisation (BIO) has fuelled even
further the ongoing debate over the potential approval path for
follow-on biologics in the country with the release of a white
paper this week that stressed that 'generic'...
A new machine developed by US firm Vardex Laser promises to offer a
unique solution to the global problem of drug counterfeiting,
protecting products right down to the pill itself.
The FDA is giving contract research organisations (CROs) the chance
to take part in a pilot designed to test the viability of
electronic case report forms (eCRF).
Active pharmaceutical ingredient (API) specialist ScinoPharm has
been assigned a drug master file (DMF) number for its anti-cancer
ingredient docetaxel, the first such designation for the API in the
US.
Discovery Laboratories has announced that a shareholder lawsuit
filed against the company was dismissed by a Pennsylvania court,
marking the end of its two-year manufacturing nightmare.
Eli Lilly & Co has withdrawn its European approval application
for Arxxant (ruboxistaurin), a potential blockbuster drug to treat
blindness caused by diabetes.
