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Hot Topics > Patient safety

Patient safety

Patient safety

Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations.

Italy bans 7 APIs from compounding pharmacies after off-label abuse

20-Aug-2015 - The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.

WuXi finds success in pilot testing of edible microtags

11-Aug-2015 - Service provider and contract manufacturer WuXi PharmaTech is vouching for TruTag Technologies’ edible microtags following a pilot project adding to evidence that they can help root out counterfeits.

Agilent and A*STAR to develop glycan analysis methods more suited to commercial setting

17-Jul-2015 - Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.

EBG BIOSIMILARS 2015

Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 - Sponsors can license biosimilars for multiple indications without performing clinical studies for each area, the EMA and FDA agree.

Academics urge updating WHO, ICH guidelines to ensure quality drugs used in clinical trials

26-Feb-2015 - The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from...

Amended Chinese GCP could aid development of CRO industry

20-Feb-2015 - The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part...

No GVK Bioscience trialled drugs under EMA spotlight are sold in Switzerland says Swissmedic

12-Feb-2015 - None of the drugs the EMA wants suspended over concerns about data manipulation at GVK Biosciences are sold in Switzerland says Swissmedic.

India aims to make new clinical trial rules permanent with draft bill

07-Jan-2015 - India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill  that would amend the country’s landmark law governing pharmaceuticals from 1940.

CDSCO says Indian hospital charged for stem cell treatments given during unapproved trial

15-Dec-2014 - Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.

USFDA issues track and trace draft guidance for third-party logistic firms

11-Dec-2014 - Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.

CROs encouraged by new NIH policy calling for single IRB to speed trials

04-Dec-2014 - CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials...

Medidata: Prepare to embrace digital biomarkers in trials or lose competitiveness

25-Nov-2014 - The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.

China sets new requirements for hospitals running clinical trials

10-Nov-2014 - The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. 

News from CPHI Paris

Doctors ask for quick-dissolve meds to stop in-patient cheating

21-Oct-2014 - Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.

Update

EMA opens investigation into India’s GVK Bio over ECG falsifications

26-Sep-2014 - At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified...

French regulator raises concerns over Indian CRO studies

25-Sep-2014 - Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical...

Pharmacies banned from compounding for docs without prescription

23-Sep-2014 - The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.

Research accreditation program signs off on three new organizations in US, Mexico

23-Sep-2014 - The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a...

Ukraine still attracting Quintiles, PPD, Icon, Parexel and INC says study

22-Sep-2014 - Political instability in Ukraine has not diminished international drug industry desire to conduct clinical trials there according to a new report.

Concerns raised over FDA’s informed consent draft guidance

22-Sep-2014 - The US FDA was flooded with comments  on its draft guidance  seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what...

update

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

17-Sep-2014 - Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in...

More new rules for trial sponsors and CROs in India

15-Sep-2014 - Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.

Industry groups take issue with FDA draft guidance on outsourcing facilities

11-Sep-2014 - Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.

Arrested: compounding pharmacist linked to 2012 meningitis deaths

09-Sep-2014 - US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012....

WIRB-Copernicus Group acquires biosafety consulting firm Alliance Biosciences

24-Jul-2014 - WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.

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