Features

New in Departments

It's the Law | 18 June 2013
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
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

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.

Read more »
Under RAPS | 30 May 2013

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.

Read more »

Regulatory Update

Content provided by
reglinks


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 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 »


In draft guidance published today, the UK’s National Institute for Health and Care Excellence (NICE) recommends Alimera’s Iluvien for certain patients with chronic diabetic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 »


The National Institute for Health and Care Excellence (NICE) yesterday issued final draft guidance recommending reimbursement for GlaxoSmithKline’s Revolade (eltrombopag) for chronic immune Read more »

Regulatory Exchange

Join the discussion -- RAPS Regulatory Exchange

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
 Search News
Search the news:
 Search
 Search Features
Search feature articles:
 Search