News

Search:
 Search

Latest News | 15 January 2013

EMA Releases Revised Anticancer Products Guideline

0 Likes

The European Medicines Agency (EMA) has released an updated scientific guideline it says will make it easier for sponsors of oncology and other anticancer medicines to conduct clinical trials.The Read More...


Latest News Regulatory Update | 18 December 2012

UK's NICE Finds Roche's Avastin Not Cost-Effective for Ovarian Cancer

0 Likes

The UK’s cost containment agency, the National Institute for health and Clinical Excellence (NICE), has issued draft guidance saying that while Roche’s blockbuster cancer drug Avastin (bevacizumab) Read More...


Latest News | 3 December 2012

FDA Releases Long-Awaited Guidance on PET Drugs

0 Likes

The US Food and Drug Administration (FDA) has released the final version of a long-awaited guidance on positron emission tomography (PET) drugs, nearly 10 months after first releasing the draft Read More...


Latest News | 4 September 2012

Astellas' Prostate Cancer Drug Receives Priority FDA Approval

0 Likes

A new drug manufactured by California-based Astellas Pharma promises to help treat aggressive, late-stage prostate cancer that has evaded other treatments, the US Food and Drug Administration (FDA) Read More...


Latest News | 7 August 2012

FDA: Send Us Your Pediatric Oncology Drugs

0 Likes

The US Food and Drug Administration (FDA) is calling for the submission of pharmaceutical and biological products worthy of being brought before its Pediatric Subcommittee of the Oncologic Drugs Read More...


Latest News | 5 June 2012

FDA Anticipates Spike in Oncology Drugs, Reduction in Shortages

0 Likes

Could 2012 be the year a long-running drought in product approvals and availability finally ends? The US Food and Drug Administration (FDA) is of the opinion that it might just be—if only for oncology Read More...


Latest News | 5 June 2012

Study: Less Affluent Less Likely to Participate in Clinical Trials

0 Likes

A study presented at the American Society of Clinical Oncology (ASCO) 2012 meeting in Chicago finds there is a strong positive correlation between the amount of money a patient makes and how likely Read More...


Latest News | 9 May 2012

Report: FDA Taking Longer to Approve Drugs With 'Unmet Medical Needs'

0 Likes

A new report published jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) is claiming the US Food and Drug Administration (FDA) is taking longer to approve Read More...


Latest News | 12 April 2012

As Final Guidance is Released, Deadline for PET Drug Compliance Draws Near

0 Likes

Manufacturers of positron emission tomography (PET) drugs have until 12 June 2012 to comply with new regulations posted by the US Food and Drug Administration (FDA) on 10 April, reports In-Pharma Read More...


Latest News | 10 April 2012

FDA Publishes New Guidance on PET Drug GMPs

0 Likes

The US Food and Drug Administration (FDA) is releasing a final guidance on positron emission tomography (PET) products to help manufacturers of the drugs meet the agency’s requirements for good Read More...


1 2
RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


New Regulatory Focus Apps for iPad and iPhone