13
Mar
High Priority - Business or Marketing Mode Concept. 3D

FDA Prioritizes ANDA for Valsartan to Avert Shortage

On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of Valsartan and other ARB medicines contain nitrosamine impurities.”  The Agency prioritized the ANDA’s […]

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12
Mar

Compounder of Sterile Products Hit with Consent Decree

A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas.  According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products.  “The government alleges that Guardian manufactured and distributed purportedly sterile drug […]

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11
Mar

Changes and Updates to the FDA’s Guidance on Non-Proprietary Naming of Biotech Products

On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>.  Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products.  This […]

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11
Mar

Tim Rhines, Ph.D., Joins Lachman Consultants as a Director in the Science and Technology Practice

Timothy Rhines, Ph.D. is a Director in the Science & Technology Practice at Lachman Consultants who is a seasoned CMC pharmaceutical / biopharmaceutical professional with more than 27 years directing CMC activities, leading analytical chemistry teams, addressing compliance gaps, compliance department leadership with P&L responsibility, implementing process excellence initiatives, developing pharmaceutical product stability operations, and […]

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08
Mar
Confused businesswoman looking at camera

Whoops! February Approval Actions at 99 or 106! But Don’t Be Fooled by the Numbers – Plus January Stat Update

Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really?  Don’t know exactly how that happened because our estimates are usually below the totals.  Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals.  However, […]

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01
Mar
Capsules in mortar

Final Guidance on Bulk Drugs that Can Be Used for Compounding for 503B Outsourcing Facilities

The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here).  After the posting of the draft guidance, the FDA says that it received approximately sixty […]

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01
Mar

Lachman Consultants to Offer Insights on Future Transition of Biological Products at the 2019 Parenteral Drug Association (PDA) Annual Meeting

(Westbury, NY – February 2019) Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs and technical services to life sciences organizations worldwide will be a Bronze Sponsor at the 2019 Annual Meeting of the Parenteral Drug Association (PDA), Booth #308, March 11-13, at the Marriott Marquis San Diego, San Diego, CA. Themed […]

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