August 7, 2014. Regxia’s clients speak: “Regxia has our heartfelt appreciation and sincere thanks for their effort and achievement in filing our Continue reading
Health Canada has released a consultation document regarding drug submissions relying on third-party data (literature and market experience). The guidance applies to Continue reading
The FDA has released a guidance for industry titled ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers. This guidance provides answers to questions from the Continue reading
May 5, 2014. Regxia’s clients speak: “I just wanted to say thank you very much for all of your help with getting our application prepared and submitted Continue reading
When finalized, the guidance for industry “Providing Regulatory Submissions in Electronic Format – Standardized Study Data” will specify and implement electronic submission requirements for study data contained in NDAs, ANDAs, certain BLAs, and certain INDs. This guidance’s requirements will also be applied to Continue reading
Thirteen prequalified companies have accepted participation in the FDA Secure Supply Chain Pilot Program to enhance the security of imported drugs. As announced in August 2013 Continue reading
On December 13, 2013 the FDA announced improvements to public databases with the intent to increase access to safety information on marketed medical devices. One of the key improvements made was Continue reading
Health Canada’s Health Products and Food Branch (HPFB) Inspectorate has notified stakeholders that Canada’s Food and Drug Regulations have been amended. The change extends Division 1A – Establishment Licensing and Division 2 – Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use Continue reading
A new FDA draft guidance has been released in an attempt to clarify the agency’s expectations around generics stability testing.
Primarily, generic drug manufacturers submitting abbreviated new drug applications (ANDAs) are “principally concerned with Continue reading
In September 2000, FDA issued the final rule “Administrative Practices and Procedures; Good Guidance Practices” (GGP). One aspect of the GGP regulation explains that the FDA will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.
As such, the Center for Drug Evaluation and Research (CDER) has launched an initiative to review draft guidance documents published before 2010 in an effort to decide which guidances to withdraw, revise, or finalize Continue reading