iwewlkws This Friday, the 4th of May 2018 is the last day FDA will accept most submissions to CDER and CBER and several to CDRH in paper format. Starting 5th of May 2018, almost all INDs, market approval applications, most DMFs, except Type III DMFs, can only be submitted electronically. Also all amendments, request for meetings, … Read more
Last week Senator Chuck Grassley of Iowa sent a letter to FDA asking about the outcome of a Warning Letter issued last year to a stem cell clinic and in the process raised issues that could affect regulation of all similar clinics by FDA. In August 2017, FDA issued a Warning Letter to US Stem … Read more
Since the inception of the Breakthrough Therapy Designation (BTD) program over 5 years ago, FDA granted this designation to 63 products, and approved 17 products under this program. But it also took back the designation from 14 of them, 5 in last year alone. That’s a whopping 22% of the BTDs; more than 1 out … Read more
This week FDA rescinded a previous decision to refuse-to-file (RTF) an NDA from Alkermes for a depression drug without the company addressing any of the deficiencies and additional data requirements listed by FDA at the time of the RTF. The company released a statement claiming that the reversal of the FDA’s decision came about due … Read more
There is a general perception that FDA regulations are overly burdensome, FDA takes long time to approve new treatments, and patients can benefit from treatments based on anecdotal data. This led to some laws passed at the state level solely intended to undermine FDA’s oversight. But these states and patients may soon face buyer’s remorse. … Read more
FDA plans to accept 510k applications for medical devices that show compliance with FDA defined standards rather than direct comparison to the predicate device by expanding its abbreviated 510k program under the least burdensome philosophy. FDA will release a list of 510k devices that could use this new program along with consensus standards and expected … Read more
Two new FDA guidance documents discuss the practical and regulatory aspects of testing new products in children and pregnant women confirming the well-established industry practices for these populations. Both documents emphasize the need to test new drugs in children and pregnant women only when absolutely necessary and to use alternate data sources to reduce clinical … Read more
FDA recently published the time-lines for the pre-approval GMP inspections for drugs and medical devices and it shows some useful time-lines for regulatory actions that may be useful to all manufacturers planning for such inspections. Prior to approval of any new drug or medical device, FDA must conduct a GMP audit of the facility where … Read more
In its latest Guidance Document and announcement for the current policy for compounding pharmacies, FDA emphasizes that the law supports only compounding drugs for which there is a clearly defined “clinical need” and not where compounded versions of approved drugs are created to make cheaper treatments for patients. The policy specifically applies to the 503B … Read more
It is assumed that greater transparency would discourage undesirable activities but experience shows that the disclosing parties become more careful and use reporting loopholes to their advantage. A review of the California law that requires companies to disclose exorbitant drug price increases seems to show little effect, if any, of such disclosure on such increases. … Read more
