Generics

08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

Read More
08
Dec

A Divorce of Sorts, as FDA Separates Guidance on Rx and OTC Proprietary Naming

In May of 2014, the FDA issued a draft guidance entitled Best Practices in Developing Proprietary Names for Drugs. This draft guidance contained recommendations for the selection of proprietary names for both prescription (Rx) and over-the-counter (OTC) medications.  In the 6-and-a-half-year interval that has passed since the issuance of this guidance, the FDA has initiated […]

Read More
03
Dec

November ANDA Approval Actions Dip from Previous Month – A Bit of a Turkey?

The unofficial November totals for approval actions and tentative-approval actions for month two of FY 2021 dropped from a total of ninety-three to seventy-two.  The seventy-two can be broken down into fifty-five full-approval actions and seventeen tentative-approval actions. As with  every month, the totals may change a bit when the OGD reports its official numbers sometime […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
1 29 30 31 122