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COMPLETE RESPONSE LETTERS DUE TO FAILED PAIS – MORE TO COME Image

Developments in Continuing Process Verification

By Don Elinski Mar 28, 2016 Compliance FDA Generics Science & Technology Validation

The key to developing a practical approach to all phases lies in the establishment of Critical Quality Attributes (CQA) for the drug product and assignment and monitoring of Critical Process Parameters (CPP) that have a direct effect on the performance of the process with regard to the CQA. At the PDA Annual Meeting last week, Scott Bazzone, Senior Manager of Quality Assurance Validation at Pfizer presented the approach that is used there with regards to establishing the risk significance or Z Score of a CPP to the CQA.

Mar

Generics Draft Abuse-Deterrent Guidance Issues

By Bob Pollock Mar 25, 2016 FDA Generics Regulatory Affairs

The questions about what and how a generic abuse-deterrent product has become somewhat more clear with the issuance today of the Draft Guidance for Industry – General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The Guidance document describes the types of tests (comparative in vitro studies and, in some cases, relevant pharmacokinetic or other studies that may be appropriate) that a generic applicant should undertake when seeking approval for a Reference Listed Drug (RLD) opioid product that has abuse-deterrent properties described in its labeling.

Mar

LCS Exhibits at PDA Annual Meeting

By Bob Pollock Mar 22, 2016 News

From March 14-15, LCS hosted a booth at the PDA Annual Meeting in San Antonio, Texas. The meeting was attended by over 850 pharmaceutical professionals, representing both industry and regulators. Linda Evans O’Connor, Director, and Michele Sinoway, Senior Manager, met with many potential clients and FDA representatives, and are sure this will be a very […]

Mar

Who Are These Guys? OGD Updates Part of Its Organizational Chart

By Bob Pollock Mar 22, 2016 Compliance FDA Generics Regulatory Affairs Science & Technology

The Office of Generic Drugs (OGD) has updated its organization chart, but trying to figure out who is who in most of the OGD Office and Divisions remains a bit mysterious. Try to find the titles and position of many of the OGD staff and you kind of run into an electronic wall. Even if you know their names, their position and location within OGD, they are not easily discernible.

Mar

Fran Zipp and Terri Nataline Present at DCAT Week

By Bob Pollock Mar 21, 2016 News

On Tuesday, March 15, 2016, our President and CEO Fran Zipp and Senior Associate Terri Nataline presented in a forum entitled “GDUFA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes” at DCAT Week. DCAT Week is the premier business development event for companies engaged in pharmaceutical development and manufacturing and […]

Mar

Complete Response Letters Reach 3rd Highest Monthly Total Under GDUFA

By Bob Pollock Mar 20, 2016 FDA Regulatory Affairs

February saw the 3rd largest number of Complete Response Letters (CRLS) issued (129) in a single month since the implementation of GDUFA. Previous highs were 134 in July FY 2015 and 130 reached in November FY 2013. With the review machine gearing up, wouldn’t one expect the number of CRLs to be steadily increasing each month? Maybe not! If the information requests (IRs) keep flying out the door along with easily correctable deficiencies (ECDs), then maybe the number of CRLs will remain lower. Or is that wishful thinking? That logic would seem to mean that the number of approvals should be soaring. Well, if you look at the total number of approval actions plus the number of CRLs, the total has actually been going up, and why? Because the number of monthly approvals has increased in FY 2016!

Mar

OGD Senior Management Responds to Yesterday’s Post

By Bob Pollock Mar 15, 2016 FDA Generics Regulatory Affairs

On Monday we posted about an issue that was brought to our attention relative to OGD’s position on goal date assignment, or lack thereof, to an ANDA with unresolved eCTD problems. We provided examples of some of the issues that firms were finding and we found that while there is merit to asking firms to […]

Mar

Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet?

By Bob Pollock Mar 14, 2016 FDA Generics Regulatory Affairs

The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Response Letters (CRLs) rather than clear movement towards application approval. Well, some three years into GDUFA I, there now seems to be a better understanding of what industry thought they got and FDA has adopted, albeit outside of the direct language in the Goals Letter, policies that are driving application towards approval.

Mar

MaPP 5240.3 on Prioritization of Original ANDAs, Amendments, and Supplements Gets a Facelift

By Bob Pollock Mar 11, 2016 FDA Generics Regulatory Affairs

Life is always a picnic and deciding what to bring is sometimes a chore. The key is to assure there are no ants! Well, the generic industry has waited to hear what would be brought to the prioritization picnic and now the third revision of the MaPP 5240.3 lays out the meal. The entire MaPP should be reviewed and studied carefully so you best understand the FDA position on priority and expedited review.

Mar

Paliperidone Palmitate BE Guidance Revised Again Image

Another Sterile Compounder Under Fire from FDA

By Bob Pollock Mar 10, 2016 Compliance FDA Generics Regulatory Affairs

FDA issued an alert today telling healthcare professionals and patients not to use human and animal sterile drug product produced by a firm in Austin, Texas. After FDA inspection of the facility which found many objectionable conditions, the Agency recommended that the firm recall its products and cease production until the problems identified were corrected. […]