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

Dietary Supplement Actions Continue

By    Jan 11, 2016    Compliance FDA Regulatory Affairs

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.”

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06
Jan

DOJ to Continue Tightening the Screws in 2016

By    Jan 06, 2016    Compliance FDA Regulatory Affairs

The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. 2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution.

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05
Jan

OGD Revises Another Bioequivalence Guidance for Long-Acting Product – The Trend Continues

By    Jan 05, 2016    FDA Generics Regulatory Affairs

FDA recently released a revised draft Guidance outlining its new thinking on the bioequivalence requirements for paliperidone palmitate, representing still another BE guidance revision for a long-acting product, but this time for a long-acting parenteral suspension of this product for schizophrenia. The original draft BE Guidance document for this injectable suspension was issued in August 2011.

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04
Jan

ANDA Applicants – WE HAVE A BINGO

By    Jan 04, 2016    FDA Generics Regulatory Affairs

December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.

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22
Dec

FDA Publishes Proposed Rule to Revise the Requirements for Combination and Co-Packaged Rx and OTC Products

By    Dec 22, 2015    Compliance FDA Generics Regulatory Affairs

In what appears to be an effort for FDA to harmonize their treatment of combination or co-packaged prescription or over-the-counter drug products, the Agency has published a 70 page Federal Register Notice addressing this issue. The proposed rule notes that “[U]nder proposed § 300.53, two or more active ingredients may be combined in a fixed-combination […]

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16
Dec

Here’s a Good Idea – Give Congress the Authority to Override FDA Decisions – NOT!

By    Dec 16, 2015    FDA Regulatory Affairs

Zachary Brennan of RAPS wrote a nice explanatory piece about a new bill introduced by Senator Ted Cruz (R-TX) and Senator Mike Lee (R-UT) called the RESULT Act, which stands for “Reciprocity Ensures Streamlined Use of Lifesaving Treatments” Act (S. 2388). In effect, the Act would permit reciprocal approvals by FDA for drugs approved in a certain list of countries. In addition, the bill would give Congress the authority to override certain non-approval decisions by FDA for drugs for life-threatening conditions and require FDA to make decisions on such drugs to treat life-threatening conditions in 30 days.

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