25
Jan

CDER Outlines Proposed Guidance Documents it Proposes to Issue in 2016

On Friday January 22, CDER issued its yearly document outlining what Guidance documents it hopes to issue in 2016.  This yearly wish list is always a highlight of the beginning of every calendar year.  The document identifies either new guidance documents FDA hopes to release, as well as those it plans to revise.  This year […]

Read More
21
Jan
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

Compounded Hormone Products Are a Big Business – Medical Groups Raise Concerns

According to a recent article in Medscape Medical News (here), the use of compounded hormone therapy to treat symptoms of menopause is a big business and accounts for a significant percentage of some compounding pharmacies income.  The article provides an estimate of $1.3 -1.6 billion annually. With the flurry of FDA enforcement actions on pharmacy […]

Read More
20
Jan

If Wall Street and the Regulators Speak – Then Something is Likely to Happen!

I recently read a very interesting article about some big vitamin companies and their stock performance. I think that it deserves some attention because, when people outside of the Food and Drug Community start writing about potential problems, and when those problems translate into increased FDA enforcement actions, then Congress takes note and then (all of a sudden) laws get rewritten and regulations get passed and, the next thing you know, a segment of the industry is changed forever – or at least until the next time the government changes its mind.

Read More
19
Jan

Court Challenge Forces Firm to Change Color of its Generic Nexium Capsule

As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.

Read More
14
Jan
Should the Term “Natural” Be Allowed on GMO Foods Image

Should the Term “Natural” Be Allowed on GMO Foods? – Well, FDA Asked and the Public Answered!

Not too often do you see the public gather around an idea so emphatically and in such numbers.  This struck me when I was looking through the public comments on Docket FDA-2014-N-1207.  To date, there are about 3000 comments posted; all are available on regulations.gov. The issue of the docket relates to the use of […]

Read More
11
Jan
Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

Dietary Supplement Actions Continue

Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.”

Read More
1 64 65 66 98