19 June 2013

Features

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It's the Law | 18 June 2013

Sunshine Act Reporting: Research Payments and Requests for Delayed Publication

On 8 February 2013, the US Centers for Medicare and Medicaid Services (CMS) issued its final rule on the reporting requirements for certain payments and other transfers of value under the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). This article focuses specifically on the issue of research and development-related payments. Read more »
Science and Technology | 5 June 2013

Fecal Transplant—a Very Unusual Treatment Method

Could anyone imagine a medical condition that would warrant administering a stool specimen from a donor? It just so happens that such treatment first occurred more than 50 years ago, and continues today. Read more »
Under RAPS | 10 June 2013

RAPS DC/Baltimore Chapter Career Day Offers Insight, Opportunity to Meet Employers

The RAPS DC/Baltimore Chapter Career Day, 11 May 2013, provided valuable insight into entering and working in the regulatory field, as well as an opportunity to speak with potential employers.

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Under RAPS | 30 May 2013

Adaptive Clinical Trials Likely to Increase; RAPS Program to Cover Regulatory Requirements

Adaptive design clinical trials can give sponsor companies the flexibility to make changes to a trial in progress without compromising the validity of its findings, but also present unique challenges. Regulatory Focus spoke to experts participating in an upcoming RAPS virtual program on adaptive trials and their regulatory requirements about their benefits, potential pitfalls and FDA expectations.

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Regulatory Update

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Brazilian Regulators Propose Switching From Paper to Electronic Permit Submissions

Posted: 17 June 2013
Brazil’s National Agency for Sanitary Surveillance (Anvisa) has opened a consultation (20/2013) regarding its proposal to switch from paper-only to e-format-only submissions for Operating Permits Read more »

India's List of API Manufacturers Confirmed for Export to EU

Posted: 17 June 2013
India’s Central Drugs Standard Control Organization (CDSCO) has posted a List of Written Confirmations Granted that sets forth 57 active pharmaceutical ingredient (API) manufacturing sites in India Read more »

NICE Recommends Treatment for Eye Problem in Diabetics

Posted: 14 June 2013
In draft guidance published today, the UK’s National Institute for Health and Care Excellence (NICE) recommends Alimera’s Iluvien for certain patients with chronic diabetic macular edema after the Read more »

GSK's Less Effective, Less Costly Bleeding Disorder Treatment Wins NICE Backing

Posted: 13 June 2013
The National Institute for Health and Care Excellence (NICE) yesterday issued final draft guidance recommending reimbursement for GlaxoSmithKline’s Revolade (eltrombopag) for chronic immune Read more »

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