Generics

24
Nov

Price Saving’s Short-Sighted Action by HHS – Unapproved Drug Initiative – Cancelled!

I marveled at the short sightedness of the Administration’s position to withdrawal the unapproved drug initiative to save the consumer money. Yes, there have been price increases when a firm has taken a previously unapproved drug product through the FDA approval system and the FDA forces the unapproved versions off the market.  Firms need to […]

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23
Nov

Lachman Consultants Wishes You a Happy Thanksgiving

At first blush, it does not seem like we have that much to be thankful for in 2020, between the pandemic, polarized political views, a contentious election, worry about loved ones, quarantine and stay at home orders, restaurants closing and opening, only outside eating, and hospitals jammed packed and people dying, jobs disappearing and Federal […]

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19
Nov

OGD Reports Approvals Receipts and CRLs for October 2020 – with a Couple of Surprises!

We got close when we reported the unofficial OGD approval actions (here) at seventy-seven and thirteen – well, the OGD’s official numbers were seventy-eight full-approval actions (the highest since May 2019) and fifteen tentative-approval actions for a total of ninety-three.  The OGD reports that nine of the seventy-eight full-approval actions were for first-time approvals.  Good way to […]

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12
Nov

Mission Critical Inspections, What About Me?  What’s a Body to Do?

Two prominent senators recently sent a letter to the Commissioner of the FDA on November 10, 2020, requesting him to provide certain information regarding the current state of conducting international inspections.  Many of those within and supportive of the pharmaceutical industry applaud the efforts of these senators in shining a light on some elements associated […]

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11
Nov

Day Three at AAM’s GRx-Biosims Virtual Conference – Some Insights

Well, here we are, at the end of the conference already.  Let us look at highlights of the Day 3 activities. Dr. Alex Azar, Secretary of Health and Human Services, gave the opening keynote address and, in usual fashion, he thanked the generics and biosimilar industries for making high-quality generic drugs and biosimilars available to […]

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11
Nov

Congress Finds Interest in Foreign Inspection Postponements Due to the Pandemic

In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic.  However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern.  On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]

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11
Nov

Complex Drugs and Complex Decisions Topped the Afternoon AAM sessions

Some of the afternoon sessions at AAM shone the light on approaching development of complex drug products including drug/device, topicals, ophthalmic products, and orally inhaled products.  Each session provided a treasure trove of information regarding the specific dosage forms and issues that the agency and industry has had to deal with.  To cover it all […]

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10
Nov

Tidbits from the Monday AAM Afternoon Sessions – and Pay Close Attention to Little viii Carve Out Issue

We all know you can’t be in two places at once (although it would certainly be handy at times).  That applies to the Association for Accessible Medicines (AAM) meeting as well.  While there are lots of good sessions, as a one-man band, some tough choices had to be made. Let’s tackle one of the most […]

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