After years of internal FDA debate, the FDA issued a guidance yesterday which was designed to assist an ANDA applicant in “determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food,
It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities. Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities (to date,
The ISPE has issued a GAMP: Records and Data Integrity guide which provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate and available throughout their lifecycle. A critical component of the data lifecycle is Data Review.
Data review should be based upon a thorough process which is defined within the procedure.
For those of us that have been around a while and are well versed in the FDA’s expectations on repackaging of solid oral dosage forms into unit dose (UD) packaging, there is really nothing new in the recently published Guidance for Industry – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products. (see full guidance here).
Looks like FDA is nearing the end of the daunting task of developing and (soon hopefully) publishing a “Difficult to Compound List” that has been in the works for nearly 17 years. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee [PCAC]) provided FDA advice about the Agency’s efforts to develop a list of drugs that present demonstrable difficulties for compounding under section 503A of the FD&C Act (version in effect in 2000).
FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures. Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend the new money that comes in for the fees.
The FDA today, in the Federal Register, announced a public workshop to be held on September 12, 2017 to discuss the use of real world data (RWD) and real world evidence (RWE) in its regulatory decision making process. The workshop, titled, “Developing a Framework for Regulatory Use of Real-World Evidence”, will be held in Washington DC.
The USP is planning to revise their USP<1058> Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP<1058> are as follows:
- The revised USP chapter introduces the concept of a user-driven risk assessment to establish the level of integrated instrument qualification to demonstrate “fitness for purpose” of the instrument.
On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations.
During the presentation, I was asked by one participant what I thought the maker of Opana ER would do.
In a recent blog post, FDA Commissioner Scott Gottlieb reinforced FDA’s plans for supporting the growing innovation in medical technology. Dr. Gottlieb reemphasized the support for digital medical technologies through the implementation of the 21st Century Cures Act, which requires FDA to clearly define those technologies that are used for the promotion of health life choices and generally exempt from,
As reported by FiercePharma here, the Supreme Court sided with biosimilar makers regarding the timing of notice to the innovator and agreed that the notice can be accomplished prior to FDA approval of the biosimilar application. Early notice could provide biosimilar applicants up to a 180-day earlier launch, meaning (obviously) a potentially earlier market entry (should everything go in their favor).
As reported by FDA WebView (here [subscription required]), FDA announced the appointment of three former congressional staffers Dr. Gottlieb has chosen to add to his current team, as his team builds his vision for the Agency is becoming more clear. And it is not the usual vision we have seen from past commissioners.
On May 8, 2017, the US FDA’s Center for Radiological Health announced that it will be establishing a new digital health unit under the Office of the Center Director. This is just the latest step the Agency is taking to try to keep pace with the quickly evolving and rapidly growing digital medical device industry.
With Scott Gottlieb, M.D., winning confirmation to head the FDA yesterday, the Agency is ready to move forward to the beat of a different drummer. It will be an interesting ride and we will watch it along the way. It also looks like the User Fee legislation may make its way to law, as it looks like the last hurdles have been cleared.
The MHRA has presented their 2016 inspectorate deficiency trend data for 2016. MHRA publishes the assessment with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement. A complete version of the MHRA presentation can be found here.
In comparison to 2015,