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Money and Morals : Ending Clinical T... [Curr Top Behav Neurosci. 2014] - PubMed - NCBI

PubMed comprises more than 23 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
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UK introduces patent infringement exemption to encourage clinical trials - Lexology (registration)

UK introduces patent infringement exemption to encourage clinical trials - Lexology (registration) | Clinical Trials | Scoop.it
UK introduces patent infringement exemption to encourage clinical trials Lexology (registration) Conducting a clinical trial of a medicine to generate data for regulatory submissions is likely to involve acts which could amount to patent...
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How Frequently Do the Results from Completed US Clinical Trials Enter the Public Domain? - A Statistical Analysis of the ClinicalTrials.gov Database

How Frequently Do the Results from Completed US Clinical Trials Enter the Public Domain? - A Statistical Analysis of the ClinicalTrials.gov Database | Clinical Trials | Scoop.it
PLOS ONE: an inclusive, peer-reviewed, open-access resource from the PUBLIC LIBRARY OF SCIENCE. Reports of well-performed scientific studies from all disciplines freely available to the whole world.
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Service tax on clinical trials faces objections - Deccan Chronicle

Service tax on clinical trials faces objections Deccan Chronicle Hyderabad: The Indian Society for Clinical Research, bio-pharma and herbal drug companies have objected to the Centre's decision to levy service tax of 12.3 per cent on the clinical...
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Indian clinical trial approvals see early spike in 2014 - OutSourcing-Pharma.com

Indian clinical trial approvals see early spike in 2014 - OutSourcing-Pharma.com | Clinical Trials | Scoop.it
OutSourcing-Pharma.com
Indian clinical trial approvals see early spike in 2014
OutSourcing-Pharma.com
CRO Theorem recently partnered with Excel Life Sciences to conduct more trials on the subcontinent.
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Big pharma opens up big data for clinical trials, analytics - Health IT Analytics

Big pharma opens up big data for clinical trials, analytics Health IT Analytics Following in the footsteps of healthcare providers who have started to realize that data must be shared openly in order for the industry as a whole to advance, some...
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Scientists call for more multi-arm clinical trials to speed up approval of new drugs - BMJ News

Scientists call for more multi-arm clinical trials to speed up approval of new drugs - BMJ News | Clinical Trials | Scoop.it

Experts have called for more multi-arm clinical trials instead of the traditional two arm studies, to allow new drugs to reach patients more quickly and to save money.


Via MRC press office
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MRC press office's curator insight, July 25, 9:57 AM

Academics from the MRC Clinical Trials Unit have recommended a change in approach to trials, in a commentary published online in the Lancet on 25 July.

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FDA Warning Letters – Their Relationship to Drug Shortages — An ...

FDA Warning Letters – Their Relationship to Drug Shortages — An ... | Clinical Trials | Scoop.it
Recently (June 12, 2014) I authored a Blog re: “FDA Warning Letters – Their Relationship to Drug Shortages”. This Blog elicited several very interesting comments. Within this Blog, I noted that Douglas C.
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7 Steps to Respond to an FDA 483 Inspection Observation

7 Steps to Respond to an FDA 483 Inspection Observation | Clinical Trials | Scoop.it
When an FDA investigator has an inspection observation, the investigator issues an FDA 483. This is the FDA's form number. If your company receives an FDA 483, how you respond to the FDA 483 is crucial to avoiding a ...
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FDA Warning Letter Close-Out Program: Audio Educator

Click here for more Information: http://www.audioeducator.com/pharma-biotech/warning-letter-close-out-program-05-06-14.html FDA Warning Letter Close-Out Prog...
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EMA Issues New Clinical Trials Regulation - Mondaq News Alerts (registration)

EMA Issues New Clinical Trials Regulation - Mondaq News Alerts (registration) | Clinical Trials | Scoop.it
EMA Issues New Clinical Trials Regulation
Mondaq News Alerts (registration)
The European Union has adopted new regulations on clinical trials that will come into force in 2016. Regulation (EU) No.
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UK Scientists Will Be Ready to Create Three-Person Babies 'in Two Years;' FDA Considering Clinical Trials of Technique in US

UK Scientists Will Be Ready to Create Three-Person Babies 'in Two Years;' FDA Considering Clinical Trials of Technique in US | Clinical Trials | Scoop.it
Scientists in the UK announced Tuesday that they will be ready to create babies using genetic material from three people in two years, once the government makes it legal, while the U.S.
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OPDP Enforcement Letters Address Omission of Risk Information ...

OPDP Enforcement Letters Address Omission of Risk Information ... | Clinical Trials | Scoop.it
OPDP Enforcement Letters Address Omission of Risk Information. May 23, 2014 – The FDA's Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date ... read more ...
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Ethics of Prehospital Clinical Research Trials Questioned

Ethics of Prehospital Clinical Research Trials Questioned | Clinical Trials | Scoop.it
Clinicians enrolled about 2,000 subjects without receiving the patients' prior consent, a rare approach that medical scholars call a necessity of circumstance.
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MCI corrupt, clinical trials body a snake pit: Harsh Vardhan

MCI corrupt, clinical trials body a snake pit: Harsh Vardhan | Clinical Trials | Scoop.it
He has called the Medical Council of India a “corrupt organisation". (MCI corrupt, clinical trials body a snake pit says @drharshvardhan.
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Will Black People Ever Trust Clinical Trials?

Will Black People Ever Trust Clinical Trials? | Clinical Trials | Scoop.it
Writer Evette Dionne recently penned a very personal yet important article about her own HPV diagnosis for Bustle.
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Clinical study potential for electronic health records - PMLiVE (blog)

Clinical study potential for electronic health records - PMLiVE (blog) | Clinical Trials | Scoop.it
Clinical study potential for electronic health records PMLiVE (blog) However, although the statin trial recruited all its required patients, eLung only managed one-fifth of its 150-patient target and Good Clinical Practice guidelines, governance...
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What Clinical Trials? Many Study Results Remain Under Wraps - Pharmalot - WSJ

Despite growing clamor for drug makers and researchers to publish clinical trial results, many studies are not disclosed to the public, according to a new study. (RT @hhask: .@pharmalot: What Clinical Trials?
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FTC releases a second order requiring preservation of records from clinical trials - Lexology (registration)

FTC releases a second order requiring preservation of records from clinical trials - Lexology (registration) | Clinical Trials | Scoop.it
FTC releases a second order requiring preservation of records from clinical trials Lexology (registration) For any future, similar claims to treat respiratory or skin conditions, or pain or inflammation, the consent order requires the named parties...
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FDA Untitled Letter for a Sponsored Link and a Webinar: In More ...

FDA Untitled Letter for a Sponsored Link and a Webinar: In More ... | Clinical Trials | Scoop.it
I crammed a lot into that title. But here is the skinny. A few weeks ago, FDA issued some new guidances around social media. This week, (yesterday) an untitled letter was posted about a sponsored link - the subject matter of ...
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Pharma sector benefits from ‘Virtual Man’ as it can clinical trials by 40%: Prof PV Mallya

Pharma sector benefits from ‘Virtual Man’ as it can clinical trials by 40%: Prof PV Mallya

Via TwoFour Insight Group
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Pharma Company's Phone Script Violates Advertising Regulations, FDA Says - Regulatory Focus

Pharma Company's Phone Script Violates Advertising Regulations, FDA Says - Regulatory Focus | Clinical Trials | Scoop.it
Regulatory Focus Pharma Company's Phone Script Violates Advertising Regulations, FDA Says Regulatory Focus Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription...
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Sun Pharma receives USFDA warning letter for Karkhadi unit

USFDA has sent a warning letter to Sun Pharmaceutical Industries with regards to the Karkhadi unit. This unit has already received an import alert which took place all the way back in March 2014.
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Social Media in Clinical Trials | 2- HEALTHCAR...

Social Media in Clinical Trials | 2-  HEALTHCAR... | Clinical Trials | Scoop.it
Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating and for engaging multiple groups involved in cancer clinical research.POOR ACCRUAL TO CLINICAL TRIALSThe clinical trial accrual for adult...
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FDA back off pharmacy compounding

#CompoundingProblem RT @RWwatchMA: No not job-killing regs Scotto, people-killing deregulations http://t.co/dzuwDfQE #masen #mapoli #p2 ...


Via Dr. Anas Bahnassi
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