Regulatory affairs is nothing if not fast-paced. As we looked back over last month's articles and updates (of which there were more than 100), we were struck by the sheer number of major developments during what is typically one of the slower months for global regulatory developments. Read on to see what those developments were and what visitors to Regulatory Focus were reading last month.
(1) FDA Announces Major Agency Reorganization, With Focus on Drug Quality
"The US Food and Drug Administration (FDA) is finally preparing to launch the Office of Pharmaceutical Quality (OPQ), a new effort to focus on the quality of drug products."
(2) FDA Announces Major Regulatory Changes, With Specialization a Key Focus
"Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products."
(3) FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions
"On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value."
(4) New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says
"The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called "New Chemical Entity" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively."
(5) In First, FDA Sends Warning Letters to Companies Citing Use of Pinterest
"The US Food and Drug Administration's (FDA) long history of Warning Letters marked a new milestone today after regulators chided three companies, including one which marketed its product on a medium never before cited by FDA: Pinterest."
(6) It's Not Just You: FDA Regulatory Requirements Really Are Increasing
"The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year."
(7) Recall or Removal? New FDA Device Guidance Clarifies Murky Definitions
"The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has finally put the finishing touches on a controversial guidance regarding how to distinguish the recall of a device from a market withdrawal."
(8) FDA Wants Input on How to Improve Clinical Trials Process for Industry
"The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process." (Link)
(9) When the FDA Inspector Comes, What are the Chances of a Really Bad Outcome?
"It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape, the specter of Murphy’s Law lurks around every corner."
(10) How NIH Hopes to Make Running Global Clinical Trials Easier for Everyone
"The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched a new website meant to make complying with clinical trial regulations around the world substantially easier."
Note: We didn't include editions of Regulatory Reconnaissance on this list. They collectively received 23,000 page views last month, with more than a few garnering enough views to make this list.