FDA Asked To Improve Approval Processes For Orphan Drugs

Lawmakers appealed to FDA Commissioner Margaret Hamburg to improve consistency of approval processes for orphan drugs, in a letter spearheaded by Senator Edward Markey.

“We write in recognition of the Food and Drug Administration (FDA’s) efforts to ensure public access to safe, innovative and novel therapeutics, particularly for rare diseases and where there are unmet medical needs, and to ask that you continue to commit to ensuring that potential new medicines are guided and reviewed consistently across the agency,” the letter stated, which was signed by 38 members of Congress. The lawmakers said that many families continue to struggle with limited options for rare diseases and development of new, more effective medical treatments often comes too slow. “Innovation of new and safe drugs is especially urgent for rare diseases, for which either no approved therapeutics or no cures currently exist,” the letter stated.

read

http://www.outsourcedpharma.com/doc/fda-asked-to-improve-approval-processes-for-orphan-drugs-0001?sectionCode=dept5&templateCode=Departments&user=2901684&source=nl:39595&utm_source=et_6214173&utm_medium=email&utm_campaign=OUTPH_2014-03-12&utm_term=2F94FA2C-DD1C-4D5F-B9A5-89863456FF33&utm_content=FDA+Asked+To+Improve+Approval+Processes+For+Orphan+Drugs

Advertisements

Author: DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

One thought on “FDA Asked To Improve Approval Processes For Orphan Drugs”

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s