Ethical principles for conducting research involving humans were originally detailed in 1978 – today, a new report is urging Congress to make updates to the decades old document.
The cold chain solution company, CSafe, has opened a new San Juan-based service center in conjunction with the launch of its new company, CSafe Puerto Rico LLC.
eClinicalHealth and Clinerion have announced a collaboration under which the companies will offer their complementary technologies jointly to hospitals and sponsor companies/CROs.
The US FDA’s decision to let Juno Therapeutics restart its JCAR015 trial is positive, but the CAR-T sector must learn from safety and efficacy findings says French biotech TxCell.
Senior leadership from key regulatory bodies gathered at the DIA 2016 Annual Meeting to discuss challenges they face as global regulators, both domestically and as part of international cooperative initiatives.
The Precision Medicine Initiative (PMI) Cohort Program is expected to launch later this year with the goal of enrolling more than one million US participants by 2020.
In their pursuit to apply criminology theory to counterfeit medications, Nigerian leaders faced death, says researcher – but the country's efforts have ultimately been successful.
With deadlines around the corner, companies are beginning to plan their serialization initiatives – a process defined by regulatory changes, says Antares Vision.
The Council of the EU has unveiled a plan to analyse the competitive landscape for pharmaceuticals in Europe in a bid to improve patients' access to medicines.
UK biopharma company Scancell was forced to halt trials of its flagship cancer immunotherapy SCIB1 because its supplies of the drug no longer meet quality specifications.
The pharma industry could learn valuable lessons from the aerospace and automotive industries when it comes to designing new products, according to Swiss researchers.
An oncology centre to support the Moonshot Initiative, conflict-of-interest guidance and calls to become independent. Welcome to in-Pharmatechnologist’s US FDA round-up.
“There are units that are doing first-in-human studies that frankly have no business doing them”
The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.
According to a recent survey, there are significant advantages to adopting eTMF – although some challenges still remain in the shift towards paperless clinical trials.
The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.
India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.
The National Institutes of Health (NIH) has issued a policy on the use of a single Institutional Review Board (IRB) for multi-site research with the goal of streamlining the IRB review processes.
Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.
The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.
The advent of low-cost, real-time technologies has made capturing real-world patient experiences easier than ever, allowing CROs to address concerns over end-use needs.
The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.
The global contract development and manufacturing organization (CDMO) announced that its Durham, North Carolina-based facility completed a successful US Food and Drug Administration (FDA) inspection.
Icon and Parexel recently announced renewals with pharma giant Pfizer, but according to analysts, PPD and an unknown fourth player may disrupt business as usual.
French authorities have started a manslaughter investigation in connection with a Ph I trial conducted by Rennes-based CRO Biotrial in which one volunteer died and five others were hospitalised.
After much speculation, Pfizer has confirmed it will renew its service agreements with its largest contract research organization customers – as analysts suspected.
CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.
Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
With the emergence of the empowered patient, the reimbursement landscape is shifting and stakeholders must navigate who really holds the power – and how this changes the definition of value.
Risk algorithms and international agreements will help ensure imported API quality, says FDA Commissioner Robert Califf but industry must also take responsibility for its own supply chain.
Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.
