Generics

24
Apr
Caution Tape

Propofol Guidance on Use in Shortage Situations -An Eerie Remembrance

Propofol is an excellent anesthetic, relatively safe with a fast induction time and relatively quick recovery time.  It is used in all types of surgical and non-surgical procedures (including intubation and time on a vent if the patient is in distress).  With all the COVID 19 cases and the resultant hospitalizations and ICU stays, the […]

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17
Apr

MAPP 5200.7 Rev. 1 Issued Regarding Filing Review for Certain Amendments and Supplements

FDA released Revision 1 to its November 12, 2015 Manual of Policy and Procedures (MAPP) 5200.7 which contains “minor clarifications and formatting”, and added Attachment 2 – Work Guide for Prior Approval Supplements: Requirements for a Filing Review. Just a reminder that a MAPP is a document that provides a transparent view into how the […]

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16
Apr
Countdown numbers flip counter. Vector isolated 0 to 9 retro style flip clock or scoreboard mechanical numbers set black on white

March 2020 Approval Actions, CRLs and Receipts and Update on Feb Metrics

Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics.  Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]

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13
Apr

FDA Takes Action to Finalize Two BE Guidances – For Guess What?

On the Federal Register prepublication page (here), the FDA gives notice of the finalization of two guidance documents providing bioequivalence recommendations for two drug products that have received a lot of recent news attention, chloroquine phosphate and hydroxychloroquine sulfate.  The two products have received attention because of the COVID-19 pandemic and the anecdotal reports of […]

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07
Apr

Regulatory Intelligence

How do companies keep up with the rapidly changing world of drug and device regulations?  Some companies have entire departments dedicated to these efforts.  Other companies have people doing it part-time, perhaps as an add-on to their primary jobs.  Some companies may not pay attention at all. Lachman offers a solution to this.  We develop […]

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24
Mar

In Times of Crisis, Cyber Threats Increase – Be Wary

As the coronavirus spreads around the globe, unfortunately so do cyber-criminal attacks.  Cyber criminals see this as a golden opportunity to capitalize.  Hackers leverage the panic, confusion, and misinformation to transmit malware, breach computer networks, set up malicious websites, and launch social engineering attacks. Early on in the coronavirus pandemic, the Cybersecurity and Infrastructure Security […]

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23
Mar

FDA to Exercise Enforcement Discretion for Certain Limited REMS ETASU Elements

Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]

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21
Mar

ADE Relief During Pandemic – But Only if You Need It!

The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency.  The FDA issued this Guidance directly with no public comment on March 20, 2020.  It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]

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