August 2018

31
Aug

Keith Webber, Ph.D., new Vice President, Biotechnology at Lachman Consultant Services, Inc.

We are pleased to announce that Keith Webber, Ph.D. has accepted the position of Vice President, Biotechnology at Lachman Consultants, effective September 1, 2018. Dr. Webber delivers scientific direction, strategic guidance, and leadership regarding biotechnology products, new drugs, and generic drugs, based on his 30+ years of combined industry, U.S. FDA, and NIH experience.  His […]

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28
Aug

BsUFA and GDUFA – Time to Pay

The Food and Drug Administration announced yesterday that the Biosimilar User Fee (BsUFA) program invoices for Fiscal Year (FY) 2019 were emailed to sponsors on August 27, 2018.  Sponsors should expect to receive their invoices by August 29, 2018.  This follows the PDUFA FY 2019 PDUFA program fee invoices which were emailed on August 15, […]

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27
Aug

Nominations to FDA Bulk Drug List for 503B Compounders Provides Three Strikes

In yesterday’s Federal Register (FR) prepublication page, the FDA described three drugs that were nominated for inclusion on the bulk list but all three were declined for the same basic reason. Inclusion on the bulk list would have provided 503B-registered compounding facilities with the ability to utilize the substances in bulk in order to prepare […]

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22
Aug

FDA Determines That Danocrine Is OK, But Not for All Indications

The FDA responds to numerous petitions each year asking for determinations as to whether products that have been withdrawn or discontinued from marketing have been so removed for safety or efficacy reasons.  Such determination is necessary to permit the continued marketing of other approved ANDAs that cite a Reference Listed Drug (RLD) as their basis […]

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21
Aug

Chew on This!

Today, the FDA finalized a draft guidance that issued on June 16, 2016 titled Quality Attribute Considerations for Chewable Tablets (here).  The document provides advice to sponsors of NDAs, ANDAs, some chemistry supplements, INDs, and manufacturers of non-application chewable products on the critical attributes that should be identified and quantified for chewable immediate release tablets. […]

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20
Aug

Training Materials related to ICH Q11 Questions & Answers – Selection and Justification of Starting Materials; The Saga Continues

In August 2018, the ICH Q11 Implementation Working Group (IWG) published training material in the form of a PowerPoint presentation for better clarification of ICH Q11 Questions & Answers – Selection & Justification of Starting Materials.  The presentation can be found here: Q11 IWG – slide deck training material (choose “read only” option to view) […]

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19
Aug

Lori-Ann Woodard, new Director, Medical Device at Lachman Consultant Services, Inc.

We are pleased to announce that Lori-Ann Woodard has accepted the position of Director, Medical Device at Lachman Consultants, effective August 20, 2018. Ms. Woodard delivers expertise in the implementation and management of Quality Management Systems for medical devices, Software as a Medical Device (SaMD), and combination products. She has more than 20 years of […]

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16
Aug

Complex Generics Get a Shot in the Arm (Leg Actually!) with First Generic Epinephrine Auto-injector Approval

The FDA announced today (here) the first approval of a generic equivalent to Epi-Pen, the combination product used to treat severe allergic reactions.  The FDA’s announcement acknowledges that approval of “complex” generics, like some combination (drug/device) products, can be very challenging. The FDA has always said that for most complex drug device products, the product […]

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