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Reducing the hurdles for complex generic drug development
FDA is issuing a draft guidance to assist ANDA applicants and prospective ANDA applicants in creating and submitting pre-ANDA meeting requests, including meeting package materials, so FDA can give better advice to sponsors looking to develop complex generic drugs.
FDA Makes Side-Effect Database Searchable
Side effects filed by patients and doctors, making it easily searchable by product, patient age, type of side effect or year it occurred.
The FDA Is Approving Drugs at a Staggering Pace
Thirty-four new drugs -- treating everything from cancer to rare genetic diseases -- have been approved so far this year.
FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program
FDA plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children.
FDA is Advancing the Goals of the Orphan Drug Act
New policies are designed to improve the efficiency of review process to ensure that new 90-day mandate to prevent new backlogs.
Patented drug launches help MNCs score over Indian peers
While the overall Indian pharma companies registered 1.4% year-on-year growth in August, MNCs clocked 6.2% growth during the month.
New approval to Lupin & Glenmark from FDA
Generic Doxycyclin hyclate tablet (lupin) & propafenone sustained-release capsules (Glenmark) got approved in US.
FD (11th): ANDA Submissions – Refuse to Receive (RTR) Guidance for Industry
Failed Clinical(BE) Studies must be submitted, but An ANDA will be Refused for Receipt if only a failed study is submitted.
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