Compliance 360 – A podcast survival guide to US FDA enforcement and compliance

Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations.

Compliance 360° is hosted by Medtech Insight

PODCAST LINEUP
June 5
Compliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready?

OGD Updates Activities Report of the Generic Drug Program – and Other Tidbits

The Office of Generic Drugs (OGD) has provided additional updates to its April 2017 metrics, as reported in the above-referenced document.  Not much excitement there but notable for another low month of Refuse-to-Receive (8), which should be good news to industry.  In addition, Drug Master File (DMF) reviews hit a low for this fiscal year at 44. 

Surprise, Surprise – More New ANDA Requirements

Anyone contemplating submitting a drug-device combination product like an autoinjector, prefilled syringe, transdermal patch (yes, transdermal patch), etc., should be prepared to address some of the device regulations or you will likely get a deficiency letter.  (To be perfectly honest, if you get these deficiencies, I think you should push back on the FDA, but that is an individual decision you must make.)

FDA has been asking to address 21 CFR 820.20,

Back on Track

 

Well, things do change in Washington these days on a minute by minute basis and the news cycle continues to amaze even the most skeptical of viewers.  Seems like the User Fee Reauthorization is back on track after the House Energy and Commerce Subcommittee rejects the call of the Secretary of HHS to reopen User Fee negotiations. 

Amendment to User Fee Legislation to Expedite Some Generics and Suitability Petitions

Usually when a clean bill such as the User Fee legislation gets amended, it could spell trouble for the bill.  However, in the case of recent bipartisan amendments to the User Fee legislation to reauthorize the User Fee Acts(UFAs), there is a clear and beneficial impact from the industry’s perspective.

The Amendment, which was paired down to remove some of the objectionable and potentially congressionally unpalatable and Agency unworkable issues (like expedited review in 150-days for certain ANDAs subject to drug shortage and where there was limited competition),

New Report, Same Problem? I Am So Confused!

Well ANDA fans, we have been trying to track ANDA approvals and tentative approvals during the month and now the FDA has given us another tool called the FDA Approved Drug Products “All Approvals” report (here) which can be run for a specific month.  In addition, the FDA Approved Drug Products daily listing (here) can now be run for a 7- or 14-day period. 

ANDA Supplements Spike in April

The Office of Generic Drugs (ODG) saw the largest number of changes being effected (CBE) supplements (618) as well the largest number of prior approval supplements (PAS) (57) so far, this fiscal year. While these numbers did not break any previous records (678 CBEs in September 2016 and 71 PAS in August 2016) they certainly show a spike from past months in FY 2017.

GMP Inspection Deficiency Data Trends for 2016 – Who is Minding the Store?

With the recent publication of the GMP Inspection trends for 2016 from the MHRA (here) and the FDA (here), companies involved with the observations might want to reconsider their internal audit processes.

If you evaluate the examples of the issues observed, you would question why internal audit programs do not catch many of the issues cited as most frequently encountered.