FDA Archives - Page 27 of 137 - Lachman Consultant Services, Inc.

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

By Webmaster Lachman Dec 08, 2020 Compliance Coronavirus Data Integrity Drugs Emerging Technology Facilities FDA FDA Generics Inspections Laboratories Manufacturing Medical Devices Regulatory Affairs Science & Technology

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 […]

Dec

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

By Bob Pollock Dec 08, 2020 Brand naming FDA Generics OTC Regulatory Affairs

In May of 2014, the FDA issued a draft guidance entitled Best Practices in Developing Proprietary Names for Drugs. This draft guidance contained recommendations for the selection of proprietary names for both prescription (Rx) and over-the-counter (OTC) medications.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 […]

Dec

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

By Bob Pollock Dec 03, 2020 Approvals FDA Generics Regulatory Affairs

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 […]

Dec

Administration Pressure on the FDA – What’s Taking So Long? Let Me Tell You Why!

By Bob Pollock Dec 01, 2020 Biologics FDA Regulatory Affairs Vaccines

I read an Axios report this morning (here) written by Jonathan Swan, indicating that FDA commissioner Stephen Hahn has been summoned to the West Wing by White House Chief of Staff Mark Meadows to explain “why he hasn’t moved faster to approve the Pfizer coronavirus vaccine“. This type of pressure has no place in science. […]

Nov

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

By Fran Zipp Nov 12, 2020 Biologics Compliance FDA Generics New Drugs Regulatory Affairs

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 […]

Nov

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October 2020 Best Month in Last Eighteen for Generic Approvals

By Bob Pollock Nov 05, 2020 ANDAs Approvals FDA Generics

Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months. That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions. Why do […]

Nov

Is FDA Finally Ready to Use Advanced Technology to Perform Inspections During the Pandemic?

By Linda Evans O'Connor Nov 04, 2020 Compliance FDA Inspections

According to the Pink Sheet, Brian Hasselbalch, in CDER’s Office of Pharmaceutical Quality, stated, at an IPAC-RS roundtable on November 2, 2020, that the FDA was developing guidance on virtual drug GMP audits and inspections using interactive video or other types of interactive tools and techniques. He noted that many companies have volunteered use of […]

Oct

FDA/DOJ Gets Tough on Illegal Dietary Ingredient DMAA

By Bob Pollock Oct 19, 2020 Compliance Dietary Ingredients Dietary Supplements FDA Regulatory Affairs

Two executives of a dietary ingredient company were sentenced to sixty months and twenty-four months in prison, respectively, for their part in the distribution of two products, Jack3d and OxyElite Pro, touted as workout weight-loss supplements, both containing DMAA, according to a Department of Justice release (here). The FDA had warned consumers about the dangers […]

Sep

FDA’s “Be Safe” Program Provides Advice on Online Pharmacies

By Bob Pollock Sep 21, 2020 Biologics FDA Generic Drugs New Drugs

The news is rife with stories about counterfeit drugs, illegal operating on-line pharmacies, on-line pharmacies dispensing sub- or super-potent medicines, some act as virtual opioid pill mills, but the FDA has launched a campaign to help consumers navigate the online pharmacy morass. Released this morning the FDA’s web page (here) asks in its opening line […]

Sep

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Official August 2020 Approvals and Receipts for ANDAs Reported

By Bob Pollock Sep 17, 2020 FDA Generics Metrics Regulatory Affairs

The Office of Generic Drugs (OGD) reported some of its official statistics for August today. As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]

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FDA

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

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

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

Administration Pressure on the FDA – What’s Taking So Long? Let Me Tell You Why!

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

October 2020 Best Month in Last Eighteen for Generic Approvals

Is FDA Finally Ready to Use Advanced Technology to Perform Inspections During the Pandemic?

FDA/DOJ Gets Tough on Illegal Dietary Ingredient DMAA

FDA’s “Be Safe” Program Provides Advice on Online Pharmacies

Official August 2020 Approvals and Receipts for ANDAs Reported

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