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Lachman and Law Firm Arnold & Porter to Host Webinar on FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics

By Webmaster Lachman Sep 01, 2022 Biologics Compliance FDA Manufacturing

Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]

Sep

Still Slugging Away at Opioid Abuse and Overdose, FDA Presents Yet Another Revised Plan

By Bob Pollock Sep 01, 2022 Drugs of abuse FDA Generics New Drugs Regulatory Affairs

The nation has been struggling with drug abuse for as long as I can remember. The current opioid crisis keeps the problem on the front page, especially with fentanyl being disguised in a drug of abuse which has become one of the most deadly drugs of abuse in the long war on drugs. FDA has […]

Aug

System and Sample Suitability – Know the Whole Story!

By Paul Mason, PhD. Aug 31, 2022 Compliance FDA Laboratories Quality System suitability

Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]

Aug

“GMP By the Sea” Reflections

By Patrick Day Aug 30, 2022 Compliance FDA Science & Technology

In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD. A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]

Aug

The Role of QC Testing

By Paul Mason, PhD. Aug 30, 2022 Compliance FDA Quality control

The EU recently issued the comprehensive GMP Annex 1 for the manufacture of sterile drug products. This guidance is broad and thorough covering all aspects of sterile product manufacture. Under the Quality Control section, (10.5) the following is referenced: The sterility test applied to the finished product should only be regarded as the last in […]

Aug

Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

OGD Updates July Statistical Report

By Bob Pollock Aug 26, 2022 ANDAs FDA Generics Regulatory Affairs Statistics

With just two months to go in FY 2022, the OGD has updated its July statistical report (here). With the hold‑up on the FY 2023-2027 User Fee legislation, some at the Agency are getting a bit nervous about their job security and firms are scrambling to try to budget for FY 2023 user fee costs; […]

Aug

Revised Q&A Guidance on Charging for Investigational Drugs Issued by FDA

By Bob Pollock Aug 23, 2022 Charging FDA IND Investigational drugs Regulatory Affairs

While FDA has allowed charging for investigational drugs since the 1987 “Charging Rule” went into effect, the Agency has been responding to questions from industry ever since. In 2009, the FDA revised the Charging Rule itself. The revised guidance (here) discusses these changes and notes that the “FDA’s regulations on charging for investigational drugs under […]

Aug

Mid-Month Peak at August 2022 ANDA Approval Actions

By Bob Pollock Aug 19, 2022 ANDAs Approval Actions FDA Generics Regulatory Affairs

Well, we just passed the midway mark for August 2022 and it looks like a potentially good month for ANDA approval actions. Thus far (at least posted through August 16th), the OGD has issued thirty full-approval actions and eleven tentative-approval actions, well on its way to a high-70s or low-to-mid-80s number of approval actions. We […]

Aug

FDA Alert Regarding the Use of Compatibility of Optional Autoinjectors for Glatiramer Acetate Products

By Bob Pollock Aug 18, 2022 Compliance FDA FDA Alert Regulatory Affairs

Today, the FDA released an alert (here) warning of potential cross-compatibility issues with the use of autoinjectors for injection of the glatiramer used for the relapsing‑remitting form of multiple sclerosis. The alert is directed at patients, caregivers, and healthcare providers. The FDA says it has “has received reports that using an autoinjector that is not […]

Aug

Now Hear This!

By Bob Pollock Aug 17, 2022 Device FDA OTC Regulatory Affairs

With the long-awaited FDA final rule on OTC hearing aids entitled Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids is now on the books, the Agency has issued a final guidance (here) on these products which explains the differences between, and the new regulatory framework for both hearing aids and personal sound […]

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The Lachman Blog

Lachman and Law Firm Arnold & Porter to Host Webinar on FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics

Still Slugging Away at Opioid Abuse and Overdose, FDA Presents Yet Another Revised Plan

System and Sample Suitability – Know the Whole Story!

“GMP By the Sea” Reflections

The Role of QC Testing

OGD Updates July Statistical Report

Revised Q&A Guidance on Charging for Investigational Drugs Issued by FDA

Mid-Month Peak at August 2022 ANDA Approval Actions

FDA Alert Regarding the Use of Compatibility of Optional Autoinjectors for Glatiramer Acetate Products

Now Hear This!

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