Indian pharma companies maintaining good compliance standards: Frances Zipp, CEO, Lachman Consultants
LCS’ CEO, Fran Zipp, was interviewed by Economic Times during a meeting of the ISPE India affiliate. Click here for the full interview.
New Record Month for ANDA Approval Actions? October Looks Good!
Although the Office of Generic Drugs (OGD) has not yet released the official approval numbers for October 2018 (which is the first month of FY 2019, and the first month of GDUFA II), it appears that a new record will be set. OGD approved 101 ANDAs, and tentatively approved 21 ANDAs for a total of […]
2018 FY OGD Statistics Finalized
Late yesterday, the OGD finalized its 2018 statistical chart in its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance which can be found here. There are some interesting figures and comparisons to previous years that are discussed below. Let’s look at refuse-to-receive (RTR) actions to start. FY 2018 saw the fewest RTRs […]
AG Epinephrine Autoinjectors get 2-Month Expiration Extension to Take Pressure off Interim Shortage
The FDA announced extended use dates for 72 lots of epinephrine autoinjectors. All of the 72 lots can be used for 2 months past the labeled expiration date, according to stability data supplied by the company and reviewed by the Agency. FDA noted in its announcement (here) that it does not expect or require the product […]
In an Unusual Move, FDA Reopens Comment Period on BE guidance for Sucralfate Suspension
While the FDA does appear to listen rather intently to comments on its bioequivalence (BE) draft guidances, and will occasionally reopen comment periods, it is still the exception rather than the rule. Today a Federal Register (FR) notice (here) announced another sixty-day comment period during which such comments will be entertained. The FR notice explains […]
Verification Systems Under DSCSA Draft Guidance Issues
With many of the Drug Supply Chain Security Act (DSCSA) requirements coming upon the industry soon, the FDA’s issuance of the draft guidance document, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, discusses the verification process and expectations of the Agency relative to ensuring that products are legitimate under the […]
OGD Off to A Good Start in FY 2019
If the first half of October is any indication of the approval performance of OGD, then we are off to a good start of FY 2019. The first eleven business days of October 2018 yielded forty-three full approvals and fourteen tentative approvals (TAs), and there are still ten business days left in October. Two big […]
Competitive Generic Therapies – Be Careful, the Clock is Running and Timing is Everything
What does 42 minutes mean for Competitive Generic Therapies (CGT) exclusivity – apparently everything, when FDA approved another product 42 minutes before commercial marketing began for the first approved applicant. We don’t know for sure if it was 42 minutes (evidence of first commercial distribution) or actually 5 hours and three minutes (when the first […]
It’s Official! OGD Breaks ANDA Approval Record!
The Office of Generic Drugs (OGD) posted its official numbers for approval actions, receipts and complete response letters in the last hour. The figures, from the Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) show that OGD broke the old record of 763 approvals achieved in FY 2017 by 18 ANDAs, […]
New Transdermal Guidances Set the Stage for 23 Revisions in Bio Recommendations
Today FDA announced finalizations in two guidance documents for transdermal systems (TDS) one relative to skin adhesion studies (here) and one related to skin irritation and sensitization studies (here). The revisions to the previous drafts came after FDA considered a number of industry comments to those drafts. With the finalization of the guidance documents, FDA […]
