Newsletter - September 15, 2016
FDA Announces Plan to Release About 100 New Guidance Documents
For the calendar year 2016, CDER at FDA plans to release more than 100 new guidance documents in 15 areas of interest. The list of guidance documents is a good indicator of FDA-industry interactions and current areas of interest and this year’s list is no different. Several of these will be eagerly awaited by the industry. There is a guidance document in the works specifically on off-label uses that seems to address the new legal environment for discussing unapproved.... Read More
Are E-Cigarettes Good Smoking Cessation Products? Depends on Who You Ask.
FDA has decided that e-cigarettes should be treated the same way as conventional cigarettes but in the medical community there are strong opinions regarding whether these products should be promoted for smoking cessation or discouraged for their potential to promote smoking. It has long been argued that electronic cigarettes are less harmful due to lack of tar, smoke and chemicals found in tobacco products. Read More..
FDA Announces Plan to Release About 100 New Guidance Documents
For the calendar year 2016, CDER at FDA plans to release more than 100 new guidance documents in 15 areas of interest. The list of guidance documents is a good indicator of FDA-industry interactions and current areas of interest and this year’s list is no different. Several of these will be eagerly awaited by the industry. There is a guidance document in the works specifically on off-label uses that seems to address the new legal environment for discussing unapproved.... Read More
Are E-Cigarettes Good Smoking Cessation Products? Depends on Who You Ask.
FDA has decided that e-cigarettes should be treated the same way as conventional cigarettes but in the medical community there are strong opinions regarding whether these products should be promoted for smoking cessation or discouraged for their potential to promote smoking. It has long been argued that electronic cigarettes are less harmful due to lack of tar, smoke and chemicals found in tobacco products. Read More..
