The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
A US HHS report on FDA oversight during trials has found that, with current procedures, the agency cannot tell whether drugmakers are disclosing complete financial information from all investigators who worked on a particular study.
The race to be the next FDA Commissioner is becoming increasingly competitive, with candidates jostling for position and interested parties attempting to influence proceedings.
Final guidance on the cooperative manufacture of licensed biologics has been issued by the FDA, which gives companies an outline of how to share responsibilities through the production process.
The proportion of women in clinical trials has become more representative, although there are still areas for improvement, according to research by the FDA.
A new avenue of inquiry has been opened in the investigation into the US Food and Drug Administration’s (FDA) ability and commitment to protect the nation’s citizens from unsafe drugs.
Contract research organisation PPD will have to forego a scheduled $25m payment from Takeda of Japan in the fourth quarter after the US Food and Drug Administration (FDA) held up approval of a product for diabetes.
Clinical trials that support the effectiveness of drugs filed for approval in the US are more likely to be published than those that are less supportive, according to researchers at the University of California at San Francisco.
The FDA has issued generics giant Ranbaxy Laboratories with two warning letters, detailing “extensive deviations from US cGMP requirements” at the firm’s manufacturing plants in Dewas and Paonta Sahib, India.
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.
The US Food and Drug Administration (FDA) is seeking feedback from the pharmaceutical industry to develop the recommendations of the Nanotechnology Task Force.
Panellists serving on the FDA's advisory committees will have stricter limits on their financial ties to industry under a raft of reforms announced by the agency yesterday.
The estimated 15 year period, $800m (€509) investment and one in 5,000 chance of successfully developing a new drug is likely to see more and more pharmaceutical firms partner with CROs in a bid to offset risk, according to a report Turner Investment...
The US Food and Drug Administration (FDA) has relaxed the regulatory good manufacturing practice (GMP) rules for drugs in early-stage clinical trials in recognition of the different requirements of trial scale and industrial scale manufacture.
The US Food and Drug Administration has resorted to a legal
challenge against India's Ranbaxy Laboratories in an ongoing
investigation into the sale of substandard drugs.
The US Food and Drug Administration (FDA) is pushing for Congress
to approve the use of more third-party inspectors as the regulatory
body attempts to police a complex global supply chain.
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.
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.
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) has defended its proposed
rule on product labelling changes made unilaterally through
"changes being effected" (CBE) supplements against
accusations from Congress, trial lawyers...
Canada's SemBioSys Genetics has begun final pre-clinical studies of
its novel plant-produced insulin product in preparation for its
submission to US regulatory authorities.
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.
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...
Questions are hanging over the role of a Chinese manufacturing
facility in the Baxter heparin scare after it has emerged that the
US Food and Drug Administration (FDA) has never inspected the
facility.
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.
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...
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.
The US Food and Drug Administration (FDA) is following the growing
pharma industry trend by embracing outsourcing as part of a
cost-saving drive - a move that is attracting strong opposition.
Baxter Healthcare remains in murky waters in regard to its infusion
pumps after announcing yesterday it would be recalling an
additional 986 of its Colleague brand pumps.
Following last year's contaminated glycerin poisonings in Panama
and last month's FDA guidance, US-PharmaTechnologist.com takes a
look at the implications of testing for the excipient glycerin in
the pharmaceutical supply...
US contract manufacturer PharmaFab has agreed to stop the
manufacturing and distribution of some of its drugs after
regulators found they were produced illegally.
The US Food and Drug Administration (FDA) has tackled escalating
concerns about the independence of its advisory committees by
proposing more stringent criteria for avoiding potential conflicts
of interest when considering potential...
Food and Drug Administration (FDA) staffing and timetabling
problems have delayed the re-inspection of Wyeth's Puerto Rico
site, the company said this week.
The Food and Drug Administration (FDA) have high hopes for the
fourth revision of the Prescription Drug User Fee Act (PDUFA),
which has proved its worth by cutting review times by up to 24
months since its introduction in 1992.
US firm Abraxis BioScience has been issued a firm warning by the
Food and Drug Administration (FDA) following concerns about
contamination of drug products and marketing violations for several
drugs.
MDS pharma has ceased operations at its bioanalytical services
facility in Blainville, Quebec in a bid to boost profitability
after an ongoing investigation of the site by the US Food and Drug
Administration (FDA).
A multi-million dollar US manufacturing contract for Acambis hinges
on whether or not the firm can satisfy the Food and Drug
Administration (FDA) that its investigational smallpox vaccine
should be approved.
