The Lachman Blog

03
Jul

Lachman Consultants Participates in the ISPE/FDA/PQRI Conference

A few weeks ago, Lachman Consultants participated in the ISPE/FDA/PQRI Quality Manufacturing Conference (“Conference”) in Alexandria, VA. For those that have never attended, this is a particularly dynamic meeting for those that are involved in manufacturing in the regulated industry. There were a myriad of presentations and workshops with members of FDA and industry professionals, […]

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02
Jul

Enforcement Date Rolled Back One Year for Elements of Drug Supply Chain Security Act

FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers  The […]

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27
Jun

Revised MaPP Gives GPS Directions for Priority Review of ANDAs and Supplements and Provides List of FDA Products Without Competition

Revision 3 of Manual of Policies and Procedures (MaPP) 5240.3 was published today and provides an update to include priority review for ANDAs for which there are fewer than three generic competitors.  The MaPP also provides boundaries around when an ANDA will be eligible for priority review by providing a more specific set of conditions, […]

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21
Jun

Body Building Dietary Supplement Manufacturers –  FDA Says, Watch Out!

While I have never been a big fan of dietary supplements, far be it for me to criticize the entire dietary supplement industry.  Clearly there are people that have clinically documented vitamin deficiencies and require supplementation as a result.   There are also certain disease states where dietary supplementation is definitively indicated.  And, like those of […]

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19
Jun

Pre-Submission Facility Correspondence for Priority Submissions – Guidance for Industry

The FDA has published guidance for the submission of facility information that is required to assure the shorter review timeframe for priority submissions.  This is a new provision of the GDUFA II negotiation and appears in the Commitment Letter. This pre-submission must be into OGD 2 months prior to submission of the priority application, supplement, […]

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19
Jun

CBO Costs Out New GDUFA II Program

The Congressional Budget Office (CBO) has scored (costed out) additional costs for the provisions of GDUFA II reauthorization over and above the $493.6 million/year (GDUFA II first year fee collection). The CBO speaks about the additional costs for the new amendments added to GDUFA II, which are believed to be over the fee collection under […]

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