13
Sep

Right to Try Final Rule for Reporting Under the Act To Publish On Wednesday

In today’s prepublication of the Federal Register appears the final rule entitled Annual Summary Reporting Requirements Under the Right to Try Act (here). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina, Right to Try Act of 2017 (Right to Try Act), was signed into law on May 30, 2018. This Act provides an […]

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23
Aug

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

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 […]

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14
Apr

FDA Issues Final Guidance on BA Studies in INDs and NDAs

Today, the FDA published the final guidance titled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” (here).  The final guidance comes after the FDA incorporated comments that it received on the draft of the same name issued on February 26, 2019.  That 2019 draft guidance replaced the March 2014 guidance titled “Bioavailability and Bioequivalence Studies […]

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14
Aug
Police Officer Making Traffic Stop

Do You Have Your Checkbook Ready? Be sure Clinicaltrials.gov Listings Are Made and Are Accurate!

FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018.  The FR Notice announcing the availability of the guidance (here) indicates […]

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17
Jul

Mary Oates to Participate in Webinar on Virtual Inspections

On Tuesday, July 21, Mary Oates, Ph.D., Vice President, Compliance Services, will be participating in a webinar organized by Informa, publishers of the Pink Sheet and Scrip. Mary will be a panelist in a session on Virtual Drug Inspections, occurring at 2 PM EST. The entire webinar series, which is taking place over a 24 […]

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22
Apr
Lightning strike from a thunderstorm

Jump in Number of Clinical Trials for COVID 19 Treatments Explodes

In a post entitled The Path Forward: Coronavirus Treatment Acceleration Program (here) penned by FDA Commissioner Steven Hahn, CBER M.D., Director Peter Marks, M.D., Ph.D., and CDER Director Janet Woodcock, M.D., the FDA describes the accelerated actions the Agency is taking to move the most promising therapeutic treatments to patients as quickly as possible. Just […]

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18
Mar

COVID-19 and Impact for Ongoing Clinical Trials – FDA Provides Guidance

With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about […]

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13
Feb
Fingerprint

What Is It? – Identity Testing Re-visited

In earlier blogs, we have written about specific technical items related to identity testing.  However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

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12
Feb
financial spreadsheet report

Promoting Confidence Through Product Quality – OPQ 2019 Annual Report

   The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products).  The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]

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